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Critical Healthcare
EUDAMEDClass IIa (EU MDR)
Ref TD DC05314Model 31G(0.25mm)×4mm
Identity
- Trade Name
- Critical Healthcare EUDAMED
- Device Name
- Insulin Pen Needle EUDAMED
- Model / Reference
- 31G(0.25mm)×4mm EUDAMEDTD DC05314 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971564461020 EUDAMED
- Basic UDI-DI
- B-16971564461020 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Critical Healthcare by Jiangsu Caina Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-16971564461020 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a8e0b871-1afc-4fa4-823e-456d0c6221e2 61 fields · synced Jun 18, 2026