웹2024년 5월 12일 · Basic UDI-DI는 데이터베이스 (아마도 EUDAMED)와 관련 문서 (예: 인증서, 자가 적합성 선언, 기술 문서 및 안정성 및 임상성과 요약)에서 의도된 목적, 위험 등급, 필수 … 웹2024년 8월 8일 · The UDI or “Unique Identification Number” Europe (as there is also one in the USA) is one of the new things that come with the new EU MDR 2024/745 and IVDR …
Overview of the EU Basic UDI-DI - Compliance Navigator
웹2024년 9월 24일 · 아래를 보시면, MDR (EU) 2024/745 규정 내 Annex VI에서 UDI-DI를 설명한 내용을 볼 수 있습니다. 'The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.' 웹2024년 11월 5일 · The UDI is the unique device identifier on product level and consists of an UDI-DI and an UDI-PI → UDI = UDI-DI + UDI-PI. Broadly speaking, it is a “part number … lhr to trv flights
Einmalige Produktkennung (UDI) - Public Health
웹2024년 3월 7일 · Aug 28, 2024. #2. The Basic UDI-DI is the ID for the product (or group of products) under EU rules. It serves, in principle, only for this purpose (for example, it's not used in the supply chain. It's used for regulatory traceability). It is, for example, the key to Eudamed for the product (or group of products). aravindh. 웹2024년 7월 17일 · When applying the criteria for a Basic UDI-DI, the following grouping can be made: Basic UDI-DI-01: all variants of the ‘simple’ diagnostic device. The intended purpose is ‘diagnosis’, there is a technical difference with the AI version; Basic UDI-DI-02: all variants of the diagnostic device using artificial intelligence. http://www.effectummedical.com/wp-content/uploads/2024/11/White-Paper-UDI.pdf mceachern harris \\u0026 watkins maple ridge