bexen medical
by Jiangsu Caina Medical Co., Ltd. 9 variants
Ref PS3008Model Disposable Safety Insulin Pen Needles
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 | Number69715644600410ZQ 56971564462971 | Date22 Nov 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- Withdrawn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
- Model / Reference
- Disposable Safety Insulin Pen Needles, PS3008
- Primary DI / UDI-DI
- 56971564462971
- Basic UDI-DI
- 69715644600410ZQ
- Unit of Use DI
- 46971564462974
- EMDN Code
- A0101010201 Hypodermic pen needles, with safety systems
- Device Class
- Class IIa
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000011217
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Jiangsu Caina Medical Co., Ltd.
Properties
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