Pen Needle
by Ningbo Caremed Medical Products Co., Ltd. 10 variants
Ref PN3080Model PN2912,PN3050,PN3051,PN3060,PN3061,PN3080,PN3081, PN3010,PN3011,PN3140,PN3150,PN3160,PN3180,PN3240, PN3250,PN3260,PN3340
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 | Number697454079004LX | Date13 Aug 2024 | 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- Withdrawn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
- Sterile insulin pen needles for single use
- Model / Reference
- PN2912, PN3050, PN3051, PN3060, PN3061, PN3080, PN3081, PN3010, PN3011, PN3140, PN3150, PN3160, PN3180, PN3240, PN3250, PN3260, PN3340
- Primary DI / UDI-DI
- 06974540790056, 06974540793354, 06974540793316
- Basic UDI-DI
- 697454079004LX
- EMDN Code
- A0101010202 Hypodermic pen needles, w/o safety systems
- Device Class
- Class IIa
- EU market of registration
- GreecePoland
Manufacturer details
- EUDAMED SRN
- CN-MF-000012684
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Ningbo Caremed Medical Products Co., Ltd.
See all devices from Ningbo Caremed Medical Products Co., Ltd. →
Properties
Other properties (13)
- Sterile: No
- 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