Identity
- Trade Name
- Oxygen mask EUDAMED
- Device Name
- Oxygen mask EUDAMED
- Model / Reference
- Adult、Pediatric EUDAMEDOM102-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013963525 EUDAMED
- Basic UDI-DI
- 697201396MU2ANNNNSOM001KX EUDAMED
- Direct Marketing DI
- 06972013963525 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 (2)
- EUDAMED 6cda9b7a-50a5-44bd-bc05-f95132c1eef3 61 fields · synced Jun 19, 2026
- EUDAMED b5cd5cf4-f7f9-43fd-aebc-0c9d07e4d6ff 61 fields · synced Jun 19, 2026