Identity
- Trade Name
- RESCUE - Sudden birth EUDAMED
- Device Name
- RESCUE - Náhlý porod EUDAMED
- Model / Reference
- 14004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18590317140043 EUDAMED
- Basic UDI-DI
- 85903170005SP EUDAMED
- EMDN Code
- V0501 CLINICAL EMERGENCY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- RESCUE – Sudden Birth kit is intended for physicians and healthcare personnel providing first aid during emergency childbirth occurring outside medical facilities. It is designed for the care of both the newborn and the mother, for securing all biological material for later specialist examination, and for recording the newborn’s vital signs immediately after birth and cord clamping, as well as at 5 and 10 minutes after cord clamping, in accordance with standardized assessment (APGAR score). EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
RESCUE - Sudden birth 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 | 85903170005SP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bioster, a.s.
- EUDAMED SRN
- CZ-PR-000051599
Sources (1)
- EUDAMED a47ecde9-22ba-4d19-8dbb-3fff0496fa86 61 fields · synced Jun 18, 2026