Identity
- Trade Name
- RESCUE - Pneumothorax EUDAMED
- Device Name
- RESCUE - Pneumothorax EUDAMED
- Model / Reference
- 14005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317140050 EUDAMED
- Basic UDI-DI
- 85903170006SR EUDAMED
- EMDN Code
- V0501 CLINICAL EMERGENCY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- RESCUE – Pneumothorax kit is designed for the management of chest injuries and traumatic pneumothorax in out-of-hospital emergency care. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
RESCUE - Pneumothorax 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 | 85903170006SR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioster, a.s.
- EUDAMED SRN
- CZ-PR-000051599
Sources (1)
- EUDAMED 27ed4886-42cf-48d9-8330-64551e1476f5 61 fields · synced Jul 8, 2026