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ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Neonates)
EUDAMEDClass IIa (EU MDR)
Ref 2004-04/NModel ULTRAMED OXYGEN FACE MASK
Identity
- Trade Name
- ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Neonates) EUDAMED
- Device Name
- ULTRAMED OXYGEN FACE MASK EUDAMED
- Model / Reference
- ULTRAMED OXYGEN FACE MASK EUDAMED2004-04/N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004254963 EUDAMED
- Basic UDI-DI
- 622300425OFM2004TL EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ULTRAMED OXYGEN FACE MASK (Medium Concentration With Tube) (Neonates) by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDR — listed in…
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 | 622300425OFM2004TL | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 49f1414e-bc96-4b6d-8b72-e03ccd9af4ff 61 fields · synced Oct 6, 2026