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Critical Healthcare
EUDAMEDClass IIa (EU MDR)
Ref TD DC05315Model 31G(0.25mm)×5mmRef TD DC05324Model 32G(0.23mm)×4mmRef TD DC05318Model 31G(0.25mm)×8mm
Identity
- Trade Name
- Critical Healthcare EUDAMED
- Device Name
- Insulin Pen Needle EUDAMED
- Model / Reference
- 31G(0.25mm)×5mm EUDAMEDTD DC05315 EUDAMED32G(0.23mm)×4mm EUDAMEDTD DC05324 EUDAMED31G(0.25mm)×8mm EUDAMEDTD DC05318 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16971564461037 EUDAMED16971564461013 EUDAMED16971564461051 EUDAMED
- Basic UDI-DI
- B-16971564461037 EUDAMEDB-16971564461013 EUDAMEDB-16971564461051 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-16971564461037 | 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 (3)
- EUDAMED ff87caa8-d254-4870-a65a-a693142bd88b 61 fields · synced Oct 6, 2026
- EUDAMED 6e3a052c-3819-480c-a431-9efd95c18634 61 fields · synced May 18, 2026
- EUDAMED 2ff82e19-8821-44a8-8527-449eb53ceee8 61 fields · synced May 18, 2026