Identity
- Trade Name
- Bedside Medical Oxygen Kit EUDAMED
- Device Name
- Bedside Medical Oxygen System EUDAMED
- Model / Reference
- 670-0100-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05052270000230 EUDAMED
- Basic UDI-DI
- 5052270BEDSIDESYSEH EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- System designed to meet regulations on board ships to supply oxygen to two patients for use when breathing assistance is needed or if oxygen therapy is required. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Bedside Medical Oxygen Kit by BNOS MediTECH — 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 | 5052270BEDSIDESYSEH | Class IIb | Active |
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Manufacturer
- Manufacturer
- B.N.O.S. Meditech Limited
- EUDAMED SRN
- UK-PR-000037512
Sources (1)
- EUDAMED 819a2abc-45c9-4300-bc5d-cb94baa15b56 61 fields · synced Jun 19, 2026