The Food and Drug Administration (FDA), in their recent rule for Unique Device Identifiers (UDI) (a system to mark and identify medical devices within the healthcare supply chain), addressed the importance of leveraging existing standards.

This tool will allow you to create, calculate, confirm, and collect UDIs. The HIBC UDI-Builder’s intuitive, easy-to-use design assists users in quickly creating globally-accepted UDIs for their products.

HIBCC’s UDI & Labeling Resource Center Getting Started: HIBCC’s Guide to UDI Compliance. Download the Guide. Apply for a Labeler Identification Code (LIC) The FDA and European Commission have identified the Health Industry Bar Code Supplier Labeling Standard (HIBC SLS) as a data standard for UDI.

The HIBCC UDI has four components to the barcode, the Data Identifier, Production Identifier, Supplemental data if desired and Mod 43 check characters)

Enter an existing UDI on our tool to retrieve product information from the FDA’s GUDID. This tool also verifies the validity of the Labeler Identification Code (LIC) in your UDI by referencing HIBCC’s LIC database. The “My HIBC UDI” tool allows you to collect and store all your UDIs in a single location for later retrieval.

2019年9月4日 · 到目前为止，欧盟总共有四家认可的医疗器械唯一标识(udi)发行实体，分别是gs1、hibcc、iccbba和ifa gmbh，医疗器械udi编码规则解密——hibcc，嘉峪检测网，检测资讯

HIBCC二维码解析验证. 通过查看左侧的解析识别结果可以看到di和pi的值与我们预期的都是一致的，可以判断该二维码符合hibcc规范要求。 HIBCC一维码

国内对UDI（Unique Device Identification）编码的规范要求，从国家药品监督管理局UDI数据库的要求来看，目前国内合法的UDI编码包括3中类型. 1、基于GS1编码体系. 2、基于 MA(IDcode) 编码体系. 3、基于 阿里健康 医疗器械唯一标识编码规范

2018年5月7日 · 目前FDA接受的UDI编码三家发放机构包括 GS1 国际物品编码协会， HIBCC 保健业商务通信委员会和 ICCBBA 国际血库自动化委员会.其中GS1的使用范围最广,和接受最高,而HIBCC作为专门的医疗行业的编码机构,在医疗行业的使用也较为普遍,医疗产品出口美国,也常被要求使用HIBC编码。 HIBC比UPN、EAN/UPC代码更早。 The Health Industry Business Communications Council（HIBCC）成立于1983年，主要是开发使用条码的数据交换标准，是 …

The HIBC Basic UDI-DI enables manufacturers to connect and identify devices with the same intended purpose, risk class and essential design and manufacturing characteristics. The HIBC Basic UDI-DI satisfies the Basic UDI-DI requirements in the European Union’s Medical Device Regulation (MDR) and In-Virto Diagnostic Regulation (IVDR).