分配给医疗器械的唯一识别码,由数字、字母或符号组成,基于标准创建的产品标识和生产标识,用于产品信息追踪和识别管理。
| 标准号 & 类别 | 标准名称 | 发布 |
|---|---|---|
| 21 CFR 830-2022 规范 |
US Food and Drug Administration's requirements for the management and review of medical device-related documents
|
2022 美国联邦法规 |
| DB12/T 1016-2020 规范 |
General requirements for design and implementation of medical device traceability system
追溯码 |
2020-12-28 天津市地方标准 |
| DB32/T 5326-2025 规范标准 |
Specification for the Design and Application of Identification in the Medical Device Traceability System
数据载体 |
2025-12-30 江苏省标准 |
| DB3212/T 1141-2023 规范 |
Implementation and Application Specifications for Unique Identification of Medical Devices
|
2023-12-12 江苏省标准 |
| DB3502/T 183-2025 规范 |
Guidelines for the implementation and application of unique identification of medical devices in medical institutions
|
2025-04-09 福建省地方标准 |
| DB3710/T 237-2024 规范 |
Medical Device Unique Identification Application Technical Specification
产品标识 |
2024-12-03 山东省地方标准 |
| DB4403/T 218-2021 规范 |
Implementation Specification for Unique Identification of Medical Devices
|
2021-12-23 广东省标准 |
| DB4403/T 219-2021 规范 |
Medical device traceability system logo design and application specification
物流单元 |
2021-12-23 广东省标准 |
| DB4403/T 220-2021 规范 |
Assignment Rules for Medical Device Product Identification
产品标识 |
2021-12-23 广东省标准 |
| DB4403/T 277-2022 接口方法 |
Medical device unique identification data interface specification
应用标识符 |
2022-12-07 广东省标准 |
| YY/T 1681-2019 术语 |
Basic terminology of unique identification system for medical devices
|
2019-07-24 行业标准-医药 |
| YY/T 1752-2020 规范 |
Medical device unique identification database basic data set
|
2020-06-30 行业标准-医药 |
| YY/T 1879-2022 |
Creation and assignment of unique identifiers for medical devices
|
2022-08-17 行业标准-医药 |
| YY/T 1942-2024 规范/规程 |
Form and content of the unique device identifier
|
2024-07-08 行业标准-医药 |
| YY/T 1943-2024 规范 |
UDI implementation and application in medical device package levels
|
2024-07-08 行业标准-医药 |
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