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Oxygen mask
EUDAMEDClass IIa (EU MDR)
Ref OM222-EModel Adult、PediatricRef OM103Ref OM223-ERef OM103-E
Identity
- Trade Name
- Oxygen mask EUDAMED
- Device Name
- Oxygen mask EUDAMED
- Model / Reference
- Adult、Pediatric EUDAMEDOM222-E EUDAMEDOM103 EUDAMEDOM223-E EUDAMEDOM103-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013963563 EUDAMED06972013963518 EUDAMED06972013963570 EUDAMED06972013963532 EUDAMED
- Basic UDI-DI
- 697201396MU2ANNNNSOM001KX EUDAMED
- Direct Marketing DI
- 06972013963563 EUDAMED06972013963518 EUDAMED06972013963570 EUDAMED06972013963532 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa 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
Oxygen mask by Multigate 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 | 697201396MU2ANNNNSOM001KX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (8)
- EUDAMED 6902d70c-7983-4e03-b024-cbfe9c7d1ce7 61 fields · synced Jul 31, 2026
- EUDAMED ef28347e-df96-40b2-b3b1-124cd1347d87 61 fields · synced May 18, 2026
- EUDAMED 28e64023-6ea1-4ff1-b0e5-c9b925c229f8 61 fields · synced May 18, 2026
- EUDAMED 6028d515-18d4-4862-a918-80d9e48038b2 61 fields · synced May 19, 2026
- EUDAMED bd875adf-4b09-4122-80d7-5b12ef9f0327 61 fields · synced Jul 10, 2026
- EUDAMED e56918e5-6394-4680-a7dc-9629b79bf916 61 fields · synced Jul 23, 2026
- EUDAMED 4c1d7d1c-ebda-467c-9b49-11fa75836fee 61 fields · synced Jul 31, 2026
- EUDAMED df8ccfe6-8ff7-43b9-89c1-37b4966541e4 61 fields · synced Jul 31, 2026