UDI Basics | FDA
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 one use...
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, modernize device...
eCFR :: 21 CFR Part 830 -- Unique Device Identification
Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of § 830.20. A UDI is composed of: (1) A device identifier —a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and.
Unique Device Identification (UDI) - Healthcare | GS1
UDI requires the label of devices to bear a globally unique device identifier captured in a data carrier (AIDC), and if applicable, its Human Readable Interpretation (HRI) on the label or the device itself. This identifier and data carrier should be based on standards from accredited issuing agencies, including GS1.
一文看懂医疗器械唯一标识（UDI）条码 - 知乎
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。
UDI | 医疗器械唯一标识（UDI）详细操作与讲解 - 健康界
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。
On September 24, 2013, FDA published a final rule establishing a unique device identification system (the UDI Rule). While some parts of the rule became effective on October 24, 2013 and some...
Unique Device Identifier - UDI - European Commission
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…
医疗器械唯一标识 (UDI)条码标签的制作与打印 - Label mx
医疗器械唯一标识 （Unique Device Identification，简称UDI），是对医疗器械在其整个生命周期赋予的身份标识，是其在产品供应链中的唯一电子“身份证”。 国家药品监督管理局于2018年2月26日发布《总局办公厅公开征求医疗器械唯一标识系统规则（征求意见稿）意见》。 同年《医疗器械唯一标识通用要求》、《医疗器械唯一标识系统基础术语》两项标准审定会召开完成。 这预示着NMPA UDI时代的到来。 UDI的申请和设计流程大致为：向签发机构申请产品编码（DI）---编 …
UDI Label - Requirements For FDA Medical Device Labels - TLP
To improve patient safety, modernize device postmarket surveillance and encourage medical device innovation, the FDA’s Unique Device Identifier labels policy was created. This policy requires a unique device identifier (UDI) to be included on …