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Critical Healthcare
EUDAMEDClass IIa (EU MDR)
Ref TD DC05316Model 31G(0.25mm)×6mm
Identity
- Trade Name
- Critical Healthcare EUDAMED
- Device Name
- Insulin Pen Needle EUDAMED
- Model / Reference
- 31G(0.25mm)×6mm EUDAMEDTD DC05316 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971564461044 EUDAMED
- Basic UDI-DI
- B-16971564461044 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-16971564461044 | 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 8f177f20-55fd-475f-b7b9-a7b0a98413ac 61 fields · synced Jun 18, 2026