2024年7月30日 · The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components. a device identifier (UDI-DI) a production identifier (UDI-PI)

Prin sistemul de atribuire a identificatorilor unici ai dispozitivelor (IUD), fiecare dispozitiv medical primește un cod numeric sau alfanumeric unic. Astfel, se facilitează identificarea clară și fără echivoc și trasabilitatea tuturor dispozitivelor de pe piață. IUD include următoarele componente:

GS1 為因應美國食品和藥物管理局（Food and Drug Administration；FDA）的 UDI 規範（Unique Device Identification System Final Rule），其醫療器材製造商需在產品上標示醫療器材單一識別系統（UDI）。 UDI 的組成內容包括產品識別（Device Identifier；DI）及生產識別（Production Identifier；PI）；於日前特別發佈對應表，如表一。 UDI 編碼及條碼內含醫療器材產品規格及生產動態之關聯資料，必須由符合醫療器材優良製造規範的製造廠來執行 UDI 標示的製程，以確 …

Understanding the UDI Format. A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following:

The UDI-DI (UDI Device Identifier) is a product identifier that must be assigned to the product itself or its pack. The UDI-PI (UDI Production Identifier) contains product information such as batch number or expiry date.

2024年12月2日 · udi 是医疗器械的“身份证”，通过建立 udi 制度，有利于运用信息化手段实现对医疗器械在研制、生产、经营和使用各环节的快速、准确识别，有利于提高医疗器械的可追溯性，有利于实现产品监管数据的共享和整合，有利于创新监管模式，提升监管效能，加强 ...

企业开通GS1 UDI服务平台，可实现在一个平台完成从厂商识别代码申请、UDI编码、备案至中国商品信息服务平台及药监局数据库、信息管理、标签设计、打印喷码等UDI实施全流程。 目前已实施UDI的医械企业，90%以上采用GS1码制，如果你的企业也遇到UDI实施问题，如果你的企业也遇到UDI实施问题可以看下图，了解GS1一站式UDI服务。 一、UDI法规基础介绍. 中国UDI的“基本法”是《医疗器械唯一标识系统规则》，这个规则是2019年8月发布的。 其基本目的是为了贯彻 …

The Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. Besides the device identifier (Global Trade Item Number GTIN), the EU regulation introduces a new identifier for UDIs: the “Basic UDI-DI” (Global Model Number, GMN), which allows grouping medical devices with ...

Aceste reglementări introduc un sistem de identificare la nivelul UE, bazat pe un Identificator Unic de dispozitiv (UDI), care va facilita trasabilitatea dispozitivelor medicale și va îmbunătăți semnificativ eficiența activităților legate de siguranța post-comercializare și monitorizarea de către autoritățile competente.

2024年9月27日 · What is the UDI or Unique Device Identification? What is the Basic UDI-DI? Where can I get the Basic UDI-DI? What is the Format of a Basic UDI-DI? What is the UDI-DI? How to create your UDI-DI & Basic UDI-DI? What is the UDI-PI? Where can I register for the UDI? Where should I place the UDI on my product?