UDI Basics | FDA - U.S. Food and Drug Administration
Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. If a device is intended for more than...
Unique Device Identification: Direct Marking of Devices | FDA
Under 21 CFR 801.45, "[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended...
Unique Device Identification System (UDI System) | FDA
When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety,...
Unique Device Identifier - UDI - European Commission - Public …
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)
UDI | 医疗器械唯一标识（UDI）详细操作与讲解 - 健康界
唯一器械标识（Unique Device Identification，缩写UDI）， 医疗器械唯一标识是指呈现在医疗器械产品或者包装上的由数字、字母或者符号组成的代码，用于对医疗器械进行唯一性识别。 UDI可以被看作医疗器械产品在供应链中的唯一“身份证”, 应包括产品标识和生产标识。 产品标识为识别注册人/备案人、医疗器械型号规格和包装的唯一代码；生产标识由医疗器械生产过程相关信息的代码组成，根据监管和实际应用需求，可包含医疗器械序列号、生产批号、生产日期、失效日期等 …
一文看懂医疗器械唯一标识（UDI）条码 - 知乎 - 知乎专栏
2019年8月27日 · 医疗器械唯一标识（Unique Device Identifier, UDI）是指采用标准在医疗器械产品或包装上附载的，由数字、字母或者符号组成的代码，用于对医疗器械进行唯一性识别，可有效提升医疗器械的科学管理效率。
医疗器械唯一标识（UDI）常见问题解答 (第一期）
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 ...
2017年3月24日 · A UDI code aims at unambiguous identification of a specific medical device. To ensure a globally standardized and harmonized system, the UDI code must be issued under the rules of a U.S. FDA-accredited issuing agency or an EU-accredited assigning agency, which includes GS1. The UDI code is a unique, alphanumeric code, which consists of two parts:
Direct Marking for FDA UDI Compliance
2016年6月9日 · Direct marking is an important component of the FDA Unique Device Identification (UDI) regulation. The purpose of UDI is to establish a standard method for identifying and tracing medical devices throughout their lifecycles – from production, to distribution, to use.
The UDI system seeks to improve the identification of medical devices by making it possible to rapidly and definitively identify a device and certain key attributes that affect its safe and ...