Identity
- Trade Name
- CoolTherm Burn Kit - Small EUDAMED
- Device Name
- Burns First Aid Kit EUDAMED
- Model / Reference
- 10061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060885040619 EUDAMED
- Basic UDI-DI
- 506013188KIT359 EUDAMED
- EMDN Code
- M0408 DRESSINGS FOR BURNS ONLY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- For burns treatment EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
CoolTherm Burn Kit - Small by Reliance Medical Ltd — Class IIb — 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 | 506013188KIT359 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Reliance Medical Ltd
- EUDAMED SRN
- UK-PR-000049208
Sources (1)
- EUDAMED a6d0b862-aac3-4f5a-affb-f62f8083f28c 61 fields · synced Jun 18, 2026