Intertek notified body Intertek also offers a global training Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. The scope of notification covers Gulf Technical Regulation Intertek is an accredited Notified Body for the Pressure Equipment Directive 2014/68/EU and can provide the conformity assessments necessary for your equipment’s certification. North America IMNB AB HQ Sweden IMNB UK IMNB Finland China and South East Asia India Sweden@s Intertek Medical Notified Body AB on Friday became the 14th notified body designated under the EU Medical Devices Regulation (MDR). Intertek offers worldwide assurance, testing, inspection and certification solutions for different industries, including medical devices. Academy Place, 1-9 Brook Street, Postal Code: CM14 5NQ, Brentwood Brentwood, UNITED KINGDOM Notified Body. APAC +86 400 886 9926. As a Nationally Recognized Testing Laboratory (NRTL) approved by OHSA, Intertek is an industry leader providing Testing, Certification and in-lab support to help you navigate the requirements of the notified body should be directly and easily accessible on the website of the notified body without any additional steps, e. The European Commission publishes a list of such notified February 15, 2018 Intertek, a leading Total Quality Assurance provider to industries worldwide, announces that it is centralising its Notified Body Medical function for the d1. We do not manufacture or sell products, nor can we handle requests for product service, warranties, or replacements. Each accreditation has a defined scope and is site-specific. Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. At Intertek Medical Notified Body (IMNB), we understand the importance of reliable and efficient auditing and certification processes. 5. Address Academy Place 1-9 Brook Street February 14, 2020. Intertek has one of the world’s largest networks of laboratories, authorised to test to UAE requirements for Cosmetics, Perfumery and Personal Care Products. This also guarantees international recognition of Intertek Semko ABs expertise, objectivity and Audit Manager at Intertek Medical Notified Body AB · Experienced medical device industry Quality Assurance and Regulatory Affairs Manager <br>Energetic, perceptive people skills with a hands-on management style <br>Effective and clear interpersonal and communication skills<br>Good knowledge of ISO 9001, EN ISO 13485 & MDD 93/42/EEC for CE Intertek Medical Notified Body (IMNB) applies for designation under MDR. Our global network of laboratories and expert engineers mean we can offer a fast turnaround time and Intertek是全球领先的全面质量保障服务机构，始终以专业、精准、快速、热情的全面质量保障服务，为 Intertek是海湾合作委员会标准化组织（GSO）认可的发放海湾地区符合性标识的指定机构（Notified Body），同时也是被海湾合作委员会认可中心（GAC 的 Intertek is a Notified Body for the Gas Appliance Regulation (GAR) and Boiler Efficiency Directive (BED), accredited by the United Kingdom Accreditation Service (UKAS). Customer Support: 131 buy meddev 2. Frequently Asked Questions: Intertek Medical Notified Body (IMNB) is designated under Medical Device Regulation (MDR) 2017/745. Intertek Medical Notified Body (IMNB) Certifikace zdravotnických prostředků podle nového nařízení o zdravotnických prostředcích MDR (2017/745) je zajišťována prostřednictvím naší nové právnické osoby Intertek Medical Notified Body AB (IMNB AB). February 15, 2018 Intertek, a leading Total Quality Assurance provider to industries worldwide, announces that it is centralising its Notified Body Medical function for the d1. Intertek Deutschland GmbH is accredited for the following directives: Noise Emission in the Environment Directive; Toy Safety Directive; Scarlet combines crafted automation with human assessment expertise. Our network of more than 1,000 laboratories and offices and over 42,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification Dec 12, 2024 · Intertek是英国经贸工业部（DTI机构）的认可实验室，可提供CE标志的认证服务（Notified Body No. Case <link rel="stylesheet" href="/single-market-compliance-space/styles-QND5FZPI. Brentwood, UK: Intertek, a leading total quality assurance provider to industries worldwide, is pleased to announce that Intertek Medical Notified Body UK Ltd (IMNB UK Ltd) has been designated against the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) by the Medicines and Healthcare products Regulatory Agency (MHRA). If you are experiencing issues with a product or have questions regarding a warranty, we kindly request that you contact the manufacturer or retailer directly. cdPXA8ucSuwHd-frvu0j_agmce3H2uwhMIpIlfdl_FMI0dJUu79KoBRv_A 04 May 2016. This uniquely positions us as the only provider in the UK that can test and certify to the full May 21, 2024 · Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, Email: IMNB@intertek. Responsibility; <link rel="stylesheet" href="/single-market-compliance-space/styles-QND5FZPI. Company No. Intertek is a leading Total Quality Assurance provider to industries worldwide. After the Date of Application of the Regulations, Notified Bodies are only able to issue certificates to new Regulations. Medical Device certification under the MDR is offered through our legal entity Intertek Medical Notified Body AB (IMNB AB), Notified Body Number NB 2862. MDR and the application process 9. Responsibility; Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, Email: IMNB@intertek. As of December 2019, there are eight notified bodies based in India, which have been registered with the CDSCO. How Intertek can support you today to gain market access to the EU, Great Britain and Northern Ireland. Intertek Brand Logo. If you are interested, please submit your resume with a cover letter. The Notified Sweden@s Intertek Medical Notified Body AB on Friday became the 14th notified body designated under the EU Medical Devices Regulation (MDR). If you would like to report an Intertek Certified/Tested product that does not appear to Intertek Medical Notified Body AB has registered with SAPHRA in recognition of SWEDAC accredited ISO 13485 certificates. Furthermore, Intertek Medical Notified Body AB is designated as a notified body to certify medical devices in Sweden. Our UK laboratory is accredited for the latest Gas Appliances Regulation EN298. Icon of an arrow. 1. Intertek is hiring technical staff and auditors globally. The prime function of a notified body is to conduct product life cycle capability governing the Intertek has been appointed in the UAE as a Notified Body for Low Voltage Equipment (LVE), Energy Efficiency Standards Labelling (EESL), lighting regulation, regulation for restriction of hazardous substances (RoHS) and equipment used in explosive atmospheres (ECAS Ex), Cosmetics, Perfumery and Personal Care Products (TR UAE GSO 1943) and is May 3, 2024 · Intertek is the industry leader with employees in 1,000 locations in over 100 countries. In addition, Intertek is an EU Notified Body under the Regulation 2016/425 on Personal Protective Equipment and a UK Approved Body for Regulation 2016/425 amended for GB. se Registered office: As address Page 1 of 4 Kanmed AB Hammarbacken 6A, Sollentuna, 191 49 , Sweden 17 May 2024 Notified Body Confirmation Letter Reference: CN00221-02 Intertek Medical Notified Body UK Ltd (the "UKAB") Impartiality & freedom from conflicts of interest It is of the utmost importance that the NB and UKAB provides its services to all interested parties without favor or discrimination, and that its decisions are not capable of being influenced by any As a notified body, Intertek is a recognized conformity assessment body, accredited under ISO 17065 and notified by a national government authority to be deemed competent to conduct product For all other batteries, a notified body will need to be involved when the requirements for a carbon footprint declaration and recycled content declaration start to apply. com The 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states have designated, until February 2008, more than 1800 notified bodies. ACTIVE. Apply for Notification Intertek Testing Services Hong Kong Ltd Address. Treestand and Harness Testing Meet the Treestand Manufacturer’s Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body . A. Intertek Medical Notified Body now can start the process of taking on applications for MDR certification. Download our brief to The Medical Devices Regulation (MDR) 2017/745 requires that the Notified Body undertakes (for products of classification IIA, IIB and III) a review of the Technical Documentation from the Approved Body: Intertek Medical Notified Body UK Ltd 8532 Legislation: Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Review by company with 1-9 people. These will be Intertek is the industry leader, with employees in 1,000 locations in over 100 countries. Intertek Medical Notified Body AB was registered 6 years ago. With 30 years of extensive experience in the industry, we Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. Below is the list of Notified Bodies established per Directive, include the identification number of each notified body as well as the tasks for which it has been notified. Intertek Solutions for IEC 60601. se Registered office: As address Page 3 of 4 4-05-21 Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate. The Gulf Standards Organization (GSO) and Gulf Cooperative Council (GCC) have granted the Intertek Medical Notified Body (IMNB) applies for designation under MDR. Intertek is an ATEX Notified Body, accredited by UKAS (UK) and Accredia (Italy), and our many years of experience certifying equipment used in Hazardous Locations and Explosive Atmospheres includes 24 Feb 2020. Chicago (December 23, 2015) - Intertek, a leading quality solutions provider to industries around the world, has received formal approval as a notified body by the Gulf Standards Organization (GSO) and Gulf Cooperative Council (GCC) to test and certify products for the Gulf Mark (G Mark) scheme. So, in other words, certificates for new Medical Devices can The medical device notified body and ISO registrar Intertek has announced it has formed a partnership with Globizz, a Japanese medical device consulting manufacturing consultancy, in what could be a violation of ISO accreditation standards and international laws. Incorporated 29 May 2018. MTIC InterCert is well known by the customers as a synonymous for CE marking thanks to its recognition by the EU as a Notified Body with the number CE0068. The Group. As a Notified Body in the EU, Intertek's scope covers products that require the highest category of validation - (AVCP System 1) which must involve the independent expertise of a Notified Body, and an FPC (Factory Production Apr 5, 2017 · Intertek是全球领先的全面质量保障服务机构，始终以专业、精准、快速、热情的全面质量保障服务，为客户制胜市场保驾护航。凭借在全球100多个国家的1,000多家实验室和分支机构、及46,000多名专业员工，Intertek致力于以创新和定制的保障、测试、检验和认证解决方案，为客户的运营和供应链带来全 23 Dec 2015 Approval Granted to Facilities in Shanghai, Hong Kong and Singapore. cdPXA8ucSuwHd-frvu0j_agmce3H2uwhMIpIlfdl_FMI0dJUu79KoBRv_A Inspection. Via Guido Miglioli 2/A20063 Cernusco sul Naviglio - Milano (MI)Country : Italy Notified Body number : 2575 CE 2577 DEKRA Testing and Certification S. Pre-application form for MDR 2017/745 certification at Intertek Medical Notified Body . g. EMEA +46 8 750 00 00. Status. This will strengthen Intertek’s Notified Bodies offering in Europe, ensuring a *Intertek consulting services provided for Appliances & Consumer Electronics are carried out by consulting experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities. This means that the company operates its business in compliance with the relevant requirements stipulated in EN 45000 and ISO/IEC 17000 series. Intertek is a notified body and can provide compliance services for all machinery and safety components (including hoverboards which the EU consider as machines, and as such will be evaluated under the requirements of the machinery directive) named in Annex IV of the Directive. Sweden Intertek Medical Notified Body AB is an active company incorporated on 29 May 2018 with the registered office located in . Ltd, M/s TUV Rheinland India Pvt. Visitors: Forskargränd 8, 722 26 Västerås Cargo: Forskargränd 6, 722 26 Västerås. Regulatory Requirements for Intertek’s Service Intertek Testing Services (Shenzhen) Ltd has been accredited as a Product Certification Body (Notified Body) for the GCC Product Certification and accredited as a GAC Accredited Testing Laboratory it can deliver one-stop toy solutions for the Intertek is an ATEX Notified Body, accredited by UKAS (UK) and Accredia (Italy), and our many years of experience certifying equipment used in Hazardous Locations and Explosive Atmospheres includes extensive ATEX Directive 2014/34/EU expertise. Responsibility; Intertek automotive services include expertise and capabilities to help automotive industry clients meet environmental standards, practices and goals. Please provide the name and contact information of the person to whom all correspondence should be addressed Intertek Medical Notified Body | Choosing the Right Notified Body. Intertek Medical Notified Body UK Ltd (the "UKAB") Impartiality & freedom from conflicts of interest It is of the utmost importance that the NB and UKAB provides its services to all interested parties without favor or discrimination, and that its decisions are not capable of being influenced by any 24 Oct 2011. Age. p. INTERTEK MEDICAL NOTIFIED BODY LOCATIONS. se Registered office: As address Page 1 of 1 4-05-21 Intertek Medical Notified Body statement on remote audits under the Regulation (EU) Based on the discovery of serious lapses at Intertek Testing Services NA Inc. Reference: Medical Devices The body is formally accredited against: Manufacturers must choose a single Notified Body (NB) entity, such as Intertek, to examine the technical design of a product and verify that the technical design of the product meets the requirements of the applicable Gulf Technical Regulations and for the issuance of an evaluation report with a Gulf Type Examination certificate. Automotive industry services: Small Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. Need help or have a question Intertek Medical Notified Body AB, Torshamnsgatan 43, Box 1103, SE -164 22 Kista, Sweden Intertek Medical Notified Body AB is a Notified Body in accordance with the requirements set out in EU Regulation 2017/745 on medical Notified Bodies Details; Notified Body - 0016 . Those regulations prohibit a certification body from providing consulting to its Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Email: IMNB@intertek. UK & EIRE +44 116 296 1620. Manufacturers need to determine whether new INTERTEK MEDICAL NOTIFIED BODY UK LIMITED - Free company information from Companies House including registered office address, filing history, accounts, annual return, To market your product in the EU, you must verify compliance to the Personal Protective Equipment Directive and obtain an assessment by a Notified Body, like Intertek. Notified Body - 0005. Buy MEDDEV 2. Intertek ScanBi Diagnostics. se Registered office: As address Page 3 of 4 4-05-21 Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate Notified Body. *Intertek consulting services provided for Industrial Equipment are carried out by consulting experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities. 2/F Garment Center , 576 Castle Peak Road ,Kowloon , Hong Kong . Active since incorporation. Intertek Medical Notified Body UK Ltd Body number 8532 Previous Body number(s) UKAS reference number 26341 Contact details. One of the first NB to achieve MDR designation. , enabling localized certification services for clients manufacturing equipment for explosive atmospheres in the European Union. Intertek Capacity. css"> Buy MEDDEV 2. We have the largest set of CompEx Training facilities associated with hazardous locations in the UK and have a satellite training facility in Sasolburg South Africa. Learn more. Call Us. Need help or have a question? +1 800 810 1195. Need help or have a question? Call a Intertek Medical Notified Body is a designated body recognised by the European Commission's New Approach Notified and Designated Organisations (NANDO) list. The headquarters for IMNB AB is in Stockholm, Sweden. North America IMNB AB HQ Sweden IMNB UK IMNB Finland China and South East Asia India All products that are subject to conformity assessment involving intervention of notified bodies shall bear the G-Marking with the number of notified body and QR-Code, starting from 1st January 2017 as mandatory requirement. Intertek Testing & Certification Limited Address. Dubai, UAE - Intertek, a leading Total Quality Assurance provider to industries worldwide, has been designated as a “Notified Body” by the Gulf Standards Organization (GSO) to issue Gulf Conformity Mark (G Mark) Certificates to locally-produced, imported and exported products across the Gulf countries. 86,1198 Qinzhou Road(North), Shanghai, China 200233 Telephone: 86-21-61278200 www. intertek. 5 bar. Be the first to submit one! :) March 30, 2022. InterCert GmbH - Group of MTIC - MTIC InterCert Srl SPS InterCert SA MTIC Academy Sagl MTIC InterCert India Private Limited. Thanks to its Notified Body status, Intertek Italia Spa can perform the conformity assessment on your PPE and issue the certificate for the EU Type examination (Module B) for the following product categories, as reported in NANDO website: • Equipment providing buoyancy aid • Equipment providing chest and groin protection Sep 18, 2024 · requirements of the Notified Body and this agreement. 2020. Please contact the respective accreditation body or the contacts listed below for further details. 24 Aug 2023. com www. 1. css"> A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. UK based Notified Bodies. Tel : 01277 321234 / 07875 633460. 0362）。另外，Intertek实验室全面的能力和资质可为您提供通往欧美市场一站式本地化测试认证服务，相关测试全部在中国本土完成，帮助个体防护装备制造商节约 5 days ago · Intertek Medical Notified Body ABTorshamnsgatan 43, Box 1103SE-164 22 KistaCountry : Sweden Notified Body number : 2862 6 days ago · INTERTEK Italia S. The European standard EN 13594 specifically addresses requirements for motorcycle gloves, setting out minimum performance levels for gloves intended for protecting motorcyclists against mechanical risks, such as abrasion, cutting, tearing, and impact. Intertek Medical Notified Body AB: Notified Bodies can then begin to issue certificates to the new regulations (IVDR and MDR) once they have been designated. Ltd, and M/s TUV Sud South Asia Pvt. Whether your business is local or global, we can help to ensure that your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. Intertek offers Medical Device Testing, Certification and Assurance solutions, helping manufacturers understand regulatory standards while bringing products to market and Notified Body services (MDR 2017/745 and MDD 93/42/EEC) Mar 25, 2024 · Intertek Medical Notified Body UK Ltd Academy Place 1-9 Brook Street Brentwood Essex CM14 5NQ United Kingdom Approved Body: Intertek Medical Notified Body UK Ltd 8532 Legislation: Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). India +91 11 4159 5539. Check if the Classification of your devices will change. We continue to have our teams based around the globe, including but not limited to North America, China, India, United Kingdom, and Sweden. 2 May 10, 2017 · Intertek provides global solutions to the hazardous locations industry with a proven track record of success supporting clients. As a leading global provider of assurance, testing, inspection, and certification services with a network of expertise and laboratories worldwide, Intertek has Apr 12, 2016 · 4月开始，Intertek天祥集团中国区CE Notified Body（以下简称NB）认证服务快捷通道正式建立，最快可在24小时内签发Notified Body Opinion（以下简称NBO）证书，Intertek凭借雄厚的专业实力和卓越的服务水平成为检测认证行业内为数不多的NB 本地发证机构 Intertek have seen false ‘certificates’ on letterheads, or the use of Intertek’s logo and/or name and Notified body number 0413, as the basis for CE marking against the Medical Device Directive or Personal Protective Equipment Directive. The CE compliance process includes testing to EN 13594 standard and Notified Body certification. Edmonton, Alberta – Intertek, a leading Total Quality Assurance provider to industries worldwide, is pleased to announce the approval of its first lab in Canada as an ATEX notified body, providing Canadian manufacturers of equipment used in explosive atmospheres with a testing and certification partner to access the European market. Chicago – Intertek, a leading provider of quality solutions to industries worldwide, announces that it has extended its notified body status under the ATEX directive to reviewers in two laboratories in the U. 6 years. without the need to register as a user of the website or provide contact data. se Registered office: As address Page 1 of 4 Kanmed AB Hammarbacken 6A, Sollentuna, 191 49 , Sweden 17 May 2024 Notified Body Confirmation Letter Reference: Sep 6, 2024 · 1. S. Phone: +46 40 69 28 001. Email Intertek Medical Notified Body UK Ltd (IMNB UK) is very pleased to announce we are now UKAS accredited for ISO 13485. Our process allows you to submit your technical file in a structured, machine-readable way, while our assessments are performed by SaMD and AI specialists. . 7d577160651b45f0. Reference: Medical The scope of our accreditation can be found here on the UKAS website: Intertek Medical Notified Body UK Limited. r. Accounts. INTERTEK TESTING SERVICES NA INC 70 Codman Hill Road Boxborough, MA 01719 Authorized Representative: Paul Coghill Phone: 440 289 5841 Local Representative: Yaqing Liu Phone: 978 635 8662 www Requirements – Notified Body Accreditation Requirements, for the indicated types of product May 25, 2021 · Intertek是全球领先的全面质量保障服务机构，始终以专业、精准、快速、热情的全面质量保障服务，为客户制胜市场保驾护航。凭借在全球100多个国家的1,000多家实验室和分支机构、及46,000多名专业员工，Intertek致力于以创新和定制的保障、测试、检验和认证解决方案，为客户的运营和供应链带来全 May 3, 2016 · As a notified body, Intertek is a recognized conformity assessment body, accredited under ISO 17065 and notified by a national government authority (BIS) to be deemed competent to conduct product verification and certification to a determined set of standards. Required to publish accounts Intertek offers comprehensive Consumer Electronics Testing and Certification solutions for manufacturer, importers and retailers helping you to market faster Electronics are carried out by consulting experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities. Chicago - Intertek, a leading quality solutions provider to industries around the world, announces the addition of its laboratory in Mexico City to its list of notified bodies able to test and certify low-voltage electrical products for the Gulf mark (G mark) scheme. This step will provide sufficient time to transfer its customers’ Certificates to the new EU based Notified Body, well before the anticipated exit date, should the need to do so arises. MDCG 2019-14 document. INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532) Check the ability of your Notified Body of serving you with MDR certification, in time for the full applicable scope of your devices. The conformity assessments are performed through various evaluation procedures that apply depending on the pressure equipment category. Apr 5, 2016 · As a G mark notified body, Intertek has been recognized as a conformity assessment body, accredited under ISO 17065 and notified by the GSO and GCC to be deemed competent to conduct product verification and certification to the G mark standards. sweden@intertek. Intertek is also certified by a Notified Body to carry out third party witnessing of welding work under the Pressure Equipment Directive (PED) – a mandatory EU product directive for the design and manufacture of pressure equipment with maximum allowable pressure greater than 0. Company status Active Company type Overseas company First UK establishment opened on 29 May 2018. Receiving the UKAS accreditation is a major milestone and The UK Market Conformity Assessment Bodies (UKMCAB) service is the definitive source and a register of UK Government appointed Conformity Assessment Bodies (CABs) See the Approved Body’s full designated scope. If you would like to report an Intertek Certified/Tested product that does not appear to The Medical Devices Regulation (MDR) 2017/745 requires that the Notified Body undertakes (for products of classification IIA, IIB and III) a review of the Technical Documentation from the manufacturer as either part of the initial certification process, as part of surveillance, recertification and / or as part of significant change notifications. INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532) Academy Place 1-9 Brook Street Brentwood Essex CM14 5NQ Contact: Sharmila Gardner. Our product directories allow you to easily verify products that carry our marks. 10-2 : rev 1 designation and monitoring of notified bodies within the framework of ec directives on medical devices from intertek inform Customer Support: +1 416-401-8730 Login to i2i Subscription Intertek. Intertek's responsibility and liability are TÜV SÜD and Intertek have been designated as UK Approved Bodies to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. com. The European Union recognizes that products vary greatly in their ‘risks’ to the users and the public. Validating the specifications, value and safety of your raw materials, products and assets. Box 1103, SE-164 22 Kista, Sweden Certificate Number: 0107192-01 Initial Certification Date: 10 July 1998 Certificate Issue Date: 27 June 2021 Certificate Expiry Date: 26 June 2024 . 15 May 2020 MDR is a new set of regulations for the manufacturing of medical devices in the EU. From the widely recognized ETL mark and OSHA NRTL approval for North America, to ATEX notified body status for Europe and IECEx certification for global markets, Intertek’s team of engineers and technicians have the Intertek Assurance and Consulting services provided for medical devices are carried out by a team of Medical Device Experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body and Certification activities. Ltd. Intertek provides safety and performance certification to nationally recognized standards for a wide range of products. Accreditations, Affiliations and Recognitions: Accreditations for Americas Accreditations for Asia Pacific 28 May 2021. css"> Intertek’s assurance solutions provide confidence and total peace of mind that your operating procedures, systems and people are functioning properly to give you a competitive advantage in the marketplace. Oct 8, 2024 · <link rel="stylesheet" href="/single-market-compliance-space/styles. The Machinery Directive also contains requirements for risk analysis. All notified bodies can be found in the NANDO (New Approach Notified and Designated Organizations) database. All accreditations are granted to the legal entities operating within Intertek. com (Intertek Medical Notified Body) Division: Regulatory Services. 4. 12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES from Intertek Inform. Email Us. Benelux +31 88 126 8888. Finland +358 10424 6211. With this new approval, Jun 26, 2023 · Intertek Semko AB is a European Union, EU, Notified Body and a global certification body. Work with Intertek. l. Notified Body Certification: Verify the readiness of your Notified Body to provide MDR certification. FC035387. Modifications to Certified Products or Changes Within a Company If it is necessary to change the design of a product that is the subject of an existing Notified Body Opinions or EU Type Examination Certificate, Intertek must validate the revised design change. Sep 4, 2024 · Intertek is an accredited Notified Body (NB 0007) by ESMA to operate certification activities under the ECAS program. APAC +86 21 53397742. (Intertek), a GOTS-approved Certification Body (CB), Global Standard gGmbH management has decided to partially suspend the work in specific areas of Intertek’s operations. INTERTEK SEMKO AB. Intertek's ATEX Certification Solutions. GSO Notified Body Examination Report Address Building No. com This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek is the industry leader, with employees in 1,000 locations in over 100 countries. QYKAMv7WLZRWOKmd-75ovOUTEoiogL1CA_lx4aMvhH4. As a Notified Body in the EU, Intertek's scope covers products that require the highest category of validation - (AVCP System 1) which must involve the independent expertise of a Notified Body, and an FPC (Factory Production Control) audit. Overseas company. A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. Intertek Medical Notified Body AB. Technologies are carried out by consulting experts of a separate legal entity who have no influence over any aspect of Intertek Notified Body activities. Via Fratelli Gracchi 2720092 Cinisello Balsamo (MI)Country : Inspection. Intertek was notified on 25 July 2024. Intertek has more than 50 years of experience evaluating all kinds of batteries, serving developers, manufacturers, and application experts worldwide. Customer Support: 131 Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. Case Buy MEDDEV 2. Information regarding Intertek Notified Body certification; Conformity assessment options; Please complete the form below to view the notified body should be directly and easily accessible on the website of the notified body without any additional steps, e. Hong Kong Hong Kong, HONG KONG What is a Notified Body? A Notified Body is an independent organization designated by an EU country to perform a set of assessments on products that are regulated by certain CE Marking directives or regulations. This also guarantees international recognition of Intertek Semko ABs expertise, objectivity and independence. Here we list some of the EU countries where Intertek is accredited as a notified body, and for which directives. TÜV ECAS Certificates of Conformity (CoC) issued by approved Notified Bodies such as Intertek are mandatory for Customs clearance and for placing the products in the UAE marketplace. Download our brief to learn more about auditing and certification services. About us; News; More for INTERTEK MEDICAL NOTIFIED BODY AB (FC035387) Overseas company address Torshamnsgatan 43, Box 1103, Kista, Sweden, 164-22 . QMS Software List Notified Body Reviews Community Conference 2021. Previously in May 2018, the CDSCO had approved three notified bodies to operate in India, namely M/s Intertek India Pvt. Please provide the name and contact information of the person to whom all correspondence should be addressed. The scope of our accreditation can be found here on the UKAS website: Intertek Medical Notified Body UK Limited Receiving the UKAS accreditation is a major milestone and a pre-requisite for designation as a UK Approved Body. Audits in around 6 months (updated 12/2022) Intertek Reviews. Leicester, England & Heudebouville, France – Intertek, a leading provider of quality and safety services to a wide range of industries around the world, announces that its network of consumer goods testing laboratories now includes two European locations approved as notified bodies to conduct EC-type examinations and issue EC-type certifications. se Registered office: As address Page 3 of 3 4-05-21 Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate The 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states have designated, until February 2008, more than 1800 notified bodies. Timeliness is crucial, so ensure that your Notified Body is equipped to support the full applicable scope of your devices within the required period. Intertek can ensure customers have continuity of Third -Party services for access to any market in Europe, Great Britain and Northern Ireland through its established accredited Notified and Approved Bodies located in the EU and the UK. Please complete the form below and submit to enter your pre-application for MDR 2017/745 certification. Intertek Semko AB is a European Union, EU, Notified Body and a global certification body. Email: agritech. Additional Phone Numbers. Looks like we don't have any reviews yet. This will strengthen Intertek’s Notified Bodies offering in Europe, ensuring a PLEASE NOTE: Intertek is an independent testing laboratory. Elevenborgsvägen 2, 230 53 Alnarp . Germany. Our team of Intertek Medical Notified Body Mar 30, 2022 · Intertek Reviews & Capacity. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Classification Review: Evaluate whether the classification of your devices is subject to 03 May 2016. Intertek Semko AB - Västerås. Benelux Intertek Notified Bodies will accept either the manufacturer’s own reports or third party reports, as long as they show compliance and seem reasonable and trustworthy. Intertek is an ATEX Notified Body, DSEAR/ATEX 137 implementation specialist and CompEx Training Centre. O. Intertek Deutschland GmbH is accredited for the following directives: Noise Emission in the Environment Directive; Toy Safety Directive; Intertek Medical Notified Body AB Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden Telephone +46 8 750 00 00, Fax +46 8 750 60 30, www. Stockholm, Sweden - Intertek, a leading Total Quality Assurance Provider to industries, is pleased to announce that the Intertek Medical Notified Body AB (IMNB) has been designated against MDR 2017/745 from the Swedish Competent Authority. The prime function of a notified body under the ATEX directive is to ascertain and Feb 15, 2018 · Head of Intertek Notified Body Medical Tel: +46 875 00480 About Intertek. Their services mentioned on their site include: As an ATEX notified body, the Intertek lab in Edmonton is authorized to evaluate, document and certify that equipment and protective systems intended for the EU market meet the relevant applicable provisions of Notified means that a member state has informed the European Commission and the other member states, that a body has been designated to carry out conformity assessment according to a directive. Intertek SEMKO AB, NB 0413, is not registered under the PPE directive in NANDO. Need help or have a question? +1 800 967 5352. 24 Oct 2011. Intertek is a notified body and can provide compliance services for all machinery and safety components (including hoverboards which the EU consider as machines, and as such will be evaluated under the requirements of the imnb@intertek. This website should be the website registered for the notified body on NANDO and not a different website of another organization. For existing devices tested to the 2 nd Edition series, the same requirements apply as for other applicable regulatory changes and changes to standards. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. se Registered office: As address Page 3 of 3 4-05-21 Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate Intertek’s assurance solutions provide confidence and total peace of mind that your operating procedures, systems and people are functioning properly to give you a competitive advantage in the marketplace. Certification Authority, Intertek Medical Notified Body AB Intertek Medical Notified Body AB P. ieasvsoweiyqruigtcbtkimkwyoetjcgsfglijpyfdnwosmaokycwk