Insulin pen needle
by Tianjin Huahong Technology Co., Ltd. United States EUDAMED
Ref NoModel Type I, Type IB, Type VI, Type V, Type X
EMDN A0101010202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69571386PN03WK | Date19 Jun 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Insulin pen needle
- Model / Reference
- Type I, Type IB, Type VI, No, Type V, Type X
- Primary DI / UDI-DI
- 06957138609145, 06957138611438
- Basic UDI-DI
- 69571386PN03WK, 69571386PN10WG
- Unit of Use DI
- 56957138609140, 56957138611433
- EMDN Code
- A0101010202, A0101010201
- Device Class
- Class IIa
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000015849
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Tianjin Huahong Technology Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (2)
- EUDAMED b64bf32d-8c98-44e4-9e67-bb81743dc9f9
- EUDAMED 06957138611438|69571386PN10WG