Pen Needle
by Tianjin Huahong Technology Co., Ltd. United States EUDAMED
Ref NoModel Type I, Type IB, Type VI
EMDN A0101010202
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69571386PD07V9 | Date6 Jan 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Pen Needle
- Model / Reference
- Type I, Type IB, Type VI, No
- Primary DI / UDI-DI
- 06957138618024
- Basic UDI-DI
- 69571386PD07V9
- Unit of Use DI
- 56957138618029
- EMDN Code
- A0101010202 Hypodermic pen needles, w/o safety systems
- Device Class
- Class IIa
- Market of Registration
- Italy
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 (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 06957138618024|69571386PD07V9