Identity
- Trade Name
- RESCUE - Fractures and bleeding EUDAMED
- Device Name
- RESCUE - Zlomeniny a krvácení EUDAMED
- Model / Reference
- 14006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317140067 EUDAMED
- Basic UDI-DI
- 85903170007ST EUDAMED
- EMDN Code
- V0501 CLINICAL EMERGENCY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- RESCUE – Fractures and Bleeding kit is designed for the management of fractures and superficial bleeding wounds and injuries. It provides both healthcare professionals and laypersons with suitable fixation and bandaging materials for managing fractures and bleeding injuries outside medical facilities. It is intended especially for the temporary treatment of abrasions, cuts, and lacerations, for administering first aid and temporarily controlling more serious arterial and venous bleeding, and for treating dislocations as well as closed and open fractures. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
RESCUE - Fractures and bleeding 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 | 85903170007ST | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioster, a.s.
- EUDAMED SRN
- CZ-PR-000051599
Sources (1)
- EUDAMED 3faf753a-3443-4320-ba5e-0d9e002e4912 61 fields · synced Jul 27, 2026