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Oxygen Mask
EUDAMEDClass IIa (EU MDR)
Ref Oxygen Mask Model XS(Neonate Standard),S(Pediatric Standard),M(Pediatric Elongated),L(Adult Standard),XL(Adult Elongated)
Identity
- Trade Name
- Oxygen Mask EUDAMED
- Device Name
- Oxygen Mask EUDAMED
- Model / Reference
- XS(Neonate Standard),S(Pediatric Standard),M(Pediatric Elongated),L(Adult Standard),XL(Adult Elongated) EUDAMEDOxygen Mask EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941298155604 EUDAMED
- Basic UDI-DI
- 69412981500988G EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Oxygen Mask by Dechomed Co., Ltd. — 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 | 69412981500988G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dechomed Co., Ltd.
- EUDAMED SRN
- CN-MF-000025556
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 42d55e49-f3b0-4291-acc0-ce1be14d3336 61 fields · synced Jun 20, 2026