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CE 인증기관 공식 전체 목록

유럽 ​​연합 인증기관 공식 목록. 반드시 최신 정보가 포함된 원본 목록을 참조하십시오.

  • 어느 연구소 또는 회사가 인증을 받았고 (지금도 유효한가요?)
  • 인증받은 내용에 따라 다릅니다 (실험실이나 회사는 특정 시험, 표준 또는 제품에 대해서만 인증을 받습니다).

에이 ~ 해야 하다, easily accessible and perfectly searchable. Never use copies on this list on other sites to insure up-to-date.

분야: 규제 업무, 품질 엔지니어링, 의료기기, 제품 규정 준수, 전자제품.
Free alternative to NANDO database, Emergo by UL, Qarad.
CE Notified Bodies Full Official List compared with NANDO database, Emergo by UL and Qarad
CE 인증기관 공식 전체 목록NANDO databaseEmergo by ULQarad
출처의 특성: The European Commission notified bodies search in the Single Market Compliance Space (SMCS). It is the authoritative register of which organisations are notified and for which tasks. It is a database, not a service.출처의 특성: The earlier New Approach Notified and Designated Organisations information system of the European Commission. Its lists show identification numbers and the tasks each body is notified for, organised by legislation.출처의 특성: A regulatory consultancy, not a register. Its notified body support service helps select a notified body and prepares MDR and IVDR audit applications.출처의 특성: A consultancy part of the QbD Group, focused on regulatory affairs and quality systems for in vitro diagnostics and medical devices. It is not a register of notified bodies.
상태: Current system. According to a Czech notifying authority, NANDO and the Noise database were merged into SMCS, and notifications are now entered through SMCS Input.상태: Merged into SMCS at Commission level. The Commission page on notified bodies still describes NANDO as the place where lists are published, so the NANDO name may remain in use for the lists.상태: Commercial service under the Emergo by UL name, following the acquisition of Emergo by UL.상태: Active company, in the IVD and medical device field since 1986 according to its site.
Data content and scope: Identification number, designation, and the scope of accreditation per body. The scope matters because a body is only notified for certain tests, standards or products, so a name alone is not enough.Data content and scope: Bodies designated by EU and EFTA countries and by countries with mutual recognition agreements or PECA protocols, listed per directive or regulation.Data content and scope: Selects notified bodies according to product type, accredited scope and experience, and states which bodies hold MDR designation. A full public list is not given on the service page.Data content and scope: Documentation and consulting: CE marking, technical documentation, performance studies, authorised representative and PRRC services. Notified body information is not offered on the home page.
비용 및 접근 방식: Free public search. Always check this source directly rather than copies on other sites, which may be outdated.비용 및 접근 방식: Free public lists.비용 및 접근 방식: Paid consulting, priced per project. No prices are shown on the service page.
언제 선택해야 할까요? Choose it to verify that a body is still notified and for exactly which scope before signing a conformity assessment contract.언제 선택해야 할까요? Choose it only when an older link or document points to it and the content needs to be matched with the SMCS entry.언제 선택해야 할까요? Choose it when a manufacturer needs help to select and approach a notified body and to prepare the application.언제 선택해야 할까요? Choose it for IVD regulatory documentation and representation tasks rather than for body verification.

다룬 주제: CE 인증기관, 인증, 유럽 연합, 공식 목록, 시험 표준, 제품 인증, 적합성 검증, 실험실 인증, 규제 요건, 인증기관 지위, 시장 진출, 적합성 평가, ISO/IEC 17025, EN ISO/IEC 17021, ISO 9001, ISO/IEC 17020 및 EN 45011.

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