Identity
- Trade Name
- RESCUE - Burns EUDAMED
- Device Name
- RESCUE - Popáleniny EUDAMED
- Model / Reference
- 14009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317140098 EUDAMED
- Basic UDI-DI
- 85903170009SX EUDAMED
- EMDN Code
- V0501 CLINICAL EMERGENCY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- RESCUE – Burns kit consists of specialized devices designed for first‑aid management of burns. It is universal and can be used by physicians, healthcare professionals, as well as laypersons. It is intended for temporary treatment of extensive superficial injuries, primarily of the skin and subcutaneous tissue, and for burns of all degrees. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
RESCUE - Burns by BIOSTER, a.s. — Class IIa — 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 | 85903170009SX | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioster, a.s.
- EUDAMED SRN
- CZ-PR-000051599
Sources (1)
- EUDAMED b87a61dd-1534-4174-aac0-e91ec4029447 61 fields · synced Aug 4, 2026