Pen needle
by Tianjin Huahong Technology Co., Ltd. United States EUDAMED
Ref NoModel Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX
EMDN A0101010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69571386PD08VB | Date14 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Pen needle
- Model / Reference
- Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX, No
- Primary DI / UDI-DI
- 06957138615313
- Basic UDI-DI
- 69571386PD08VB
- Unit of Use DI
- 56957138615318
- EMDN Code
- A0101010201 Hypodermic pen needles, with 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 06957138615313|69571386PD08VB