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CVN Arctic Pallas Hypothermia Bag
EUDAMEDClass I (EU MDR)
Ref 5000-5016EModel H5000
Identity
- Trade Name
- CVN Arctic Pallas Hypothermia Bag EUDAMED
- Device Name
- CVN Arctic EUDAMED
- Model / Reference
- H5000 EUDAMED5000-5016E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06429810144218 EUDAMED
- Basic UDI-DI
- 6429810144H5000QW EUDAMED
- Direct Marketing DI
- 06429810144218 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 Pallas Hypothermia Bag 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 8e48ccc8-b41a-4107-b327-d9361d45c56f 61 fields · synced Jun 20, 2026