← Back to catalogue
ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Adult Standard)
EUDAMEDClass IIa (EU MDR)
Ref 2007-01Model ULTRAMED OXYGEN FACE MASK (With Nebulizer) Model ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Adult Standard)
Identity
- Trade Name
- ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Adult Standard) EUDAMED
- Device Name
- ULTRAMED OXYGEN FACE MASK EUDAMED
- Model / Reference
- ULTRAMED OXYGEN FACE MASK (With Nebulizer) EUDAMED2007-01 EUDAMEDULTRAMED OXYGEN FACE MASK (With Nebulizer) (Adult Standard) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004251634 EUDAMED
- Basic UDI-DI
- 622300425OFM2007TS EUDAMEDB-06223004251634 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ULTRAMED OXYGEN FACE MASK (With Nebulizer) (Adult Standard) by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 622300425OFM2007TS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 622300425OFM2007TS | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 82e3b829-e422-437f-9015-b26ccd7492cc 61 fields · synced Oct 6, 2026
- EUDAMED 645c68b5-4810-42d3-90c1-7af3b079603e 61 fields · synced May 18, 2026