Identity
- Trade Name
- Medical Kit EUDAMED
- Device Name
- Arctic Heat Cooling Products EUDAMED
- Model / Reference
- DMEDKIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09329754000007 EUDAMED
- Basic UDI-DI
- 9329754CKCVA3M EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Category: Hot/cold therapy pack, reusable
Medical Kit by Arctic Heat Pty Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 9329754CKCVA3M | Class I | Active |
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Manufacturer
- Manufacturer
- Arctic Heat Pty Ltd
- EUDAMED SRN
- AU-MF-000012815
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 2414bebb-ee98-47a5-850f-0cd6606e088b 61 fields · synced Jun 18, 2026