Identity
- Trade Name
- RESCUE - Thoracic drainage PROFI EUDAMED
- Device Name
- RESCUE - Drenáž hrudníku PROFI EUDAMED
- Model / Reference
- 14007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317140074 EUDAMED
- Basic UDI-DI
- 85903170008SV EUDAMED
- EMDN Code
- V0501 CLINICAL EMERGENCY KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- RESCUE – Thoracic Drainage PROFI kit is designed primarily for use by professional emergency medical personnel for the management of lung perforation and the resulting pneumothorax. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
RESCUE - Thoracic drainage PROFI by BIOSTER, a.s. — 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 | 85903170008SV | Class IIb | Active |
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Manufacturer
- Manufacturer
- Bioster, a.s.
- EUDAMED SRN
- CZ-PR-000051599
Sources (1)
- EUDAMED d7c138cf-87a5-4d59-bf6c-d06579ed611e 61 fields · synced Jul 24, 2026