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OM-2 Mask, Adult
EUDAMEDClass IIa (EU MDR)
Ref AO0086Model (D) Oxygen TherapyRef AO0133Ref AO0152
Identity
- Trade Name
- OM-2 Mask, Adult EUDAMEDOM-2 Mask, Adult w/Tubing EUDAMED
- Device Name
- Oxygen Mask EUDAMEDHi-Oxygen Mask EUDAMED
- Model / Reference
- (D) Oxygen Therapy EUDAMEDAO0086 EUDAMEDAO0133 EUDAMEDAO0152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810084829 EUDAMED04710810082795 EUDAMED04710810106828 EUDAMED
- Basic UDI-DI
- 471081008NND276 EUDAMED471081008NND378 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
OM-2 Mask, Adult by GaleMed Corporation — 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 | 471081008NND276 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 9b1974a5-c280-4b3d-bcb3-d4a934ef8740 61 fields · synced Jul 18, 2026
- EUDAMED a2b04814-1596-41cb-a733-a748cbf1981b 61 fields · synced May 17, 2026
- EUDAMED ff1a751d-c00f-4307-8854-b41b87ab2f8a 61 fields · synced May 19, 2026