Identity
- Trade Name
- DermaPlast ACTIVE Coolfix EUDAMED
- Device Name
- Cooling Bandage EUDAMED
- Model / Reference
- 1083 EUDAMED522013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611600996865 EUDAMED
- Basic UDI-DI
- 76116001083M4 EUDAMED
- EMDN Code
- M03040299 ELASTIC SUPPORT BANDAGES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
DermaPlast ACTIVE Coolfix by Ivf Hartmann Ag — 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 | 76116001083M4 | Class I | Active |
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Manufacturer
- Manufacturer
- Ivf Hartmann Ag
- EUDAMED SRN
- CH-MF-000015962
- Authorised Representative
- PAUL HARTMANN AG DE-AR-000007519
Sources (1)
- EUDAMED b0971395-4d87-42c6-8a3c-d4dc9b023c79 61 fields · synced Jun 19, 2026