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CVN Arctic Polar Hypothermia Bag OD/RG
EUDAMEDClass I (EU MDR)
Ref H5000-6345AModel H5000
Identity
- Trade Name
- CVN Arctic Polar Hypothermia Bag OD/RG EUDAMED
- Device Name
- CVN Arctic EUDAMED
- Model / Reference
- H5000 EUDAMEDH5000-6345A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429810144935 EUDAMED
- Basic UDI-DI
- 6429810144H5000QW EUDAMED
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CVN Arctic Polar Hypothermia Bag OD/RG by Carevision Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6429810144H5000QW | Class I | Active |
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Manufacturer
- Manufacturer
- Carevision Oy
- EUDAMED SRN
- FI-MF-000032554
Sources (1)
- EUDAMED e851cfbf-99a4-4667-9ee1-16965ab66046 61 fields · synced Jun 18, 2026