Identity
- Trade Name
- M-Plast Cooling bandage EUDAMED
- Device Name
- Cooling Bandage EUDAMED
- Model / Reference
- 1083 EUDAMED589005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611600995592 EUDAMED
- Basic UDI-DI
- 76116001083M4 EUDAMED
- EMDN Code
- M03040299 ELASTIC SUPPORT BANDAGES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
M-Plast Cooling bandage 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 ac0610b0-0601-40ce-8077-038d1c58c0d8 61 fields · synced Oct 6, 2026