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ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Paediatric Standard)
EUDAMEDClass IIa (EU MDR)
Ref 2008-02Model ULTRAMED OXYGEN FACE MASK Model ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Paediatric Standard)
Identity
- Trade Name
- ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Paediatric Standard) EUDAMED
- Device Name
- ULTRAMED OXYGEN FACE MASK EUDAMED
- Model / Reference
- ULTRAMED OXYGEN FACE MASK EUDAMED2008-02 EUDAMEDULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Paediatric Standard) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004253355 EUDAMED
- Basic UDI-DI
- 622300425OFM2004TL EUDAMEDB-06223004253355 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ULTRAMED OXYGEN FACE MASK (With Non-Rebreathing Bag) (Paediatric Standard) by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDD, MDR…
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 | 622300425OFM2004TL | Class IIa | Active |
| 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 (2)
- EUDAMED 108b111d-9c7b-470b-a613-eaa474dbe597 61 fields · synced Oct 6, 2026
- EUDAMED c8e2d254-c37c-4412-b9c6-59c962acd4ed 61 fields · synced May 18, 2026