Pen needle
by Tianjin Huahong Technology Co., Ltd. 89 variants
Ref NoModel Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69571386PD08VB 06957138612725 | Date14 Oct 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- 06957138612725
- Basic UDI-DI
- 69571386PD08VB
- Unit of Use DI
- 56957138612720
- EMDN Code
- A0101010201 Hypodermic pen needles, with safety systems
- Device Class
- Class IIa
- EU 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
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