Critical Healthcare
by Jiangsu Caina Medical Co., Ltd. 5 variants
Ref TD DC05324Model 32G(0.23mm)×4mm
Active
CE MDD
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/MDD | NumberB-16971564461013 16971564461013 | Date22 Nov 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Insulin Pen Needle
- Model / Reference
- 32G(0.23mm)×4mm, TD DC05324
- Primary DI / UDI-DI
- 16971564461013
- Basic UDI-DI
- B-16971564461013
- EMDN Code
- A0101010202 Hypodermic pen needles, w/o safety systems
- Device Class
- Class IIa
- EU market of registration
- Ireland
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 (9)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Measuring Function: No
- Incorporates Medicinal Product: No