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OM-1 Mask, Adult
EUDAMEDClass IIa (EU MDR)
Ref AO0128Model (D) Oxygen TherapyRef AO0089
Identity
- Trade Name
- OM-1 Mask, Adult EUDAMEDOM-1 HiO2 Mask, Adult w/Tubing EUDAMED
- Device Name
- Oxygen Mask EUDAMEDHi-Oxygen Mask EUDAMED
- Model / Reference
- (D) Oxygen Therapy EUDAMEDAO0128 EUDAMEDAO0089 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810084720 EUDAMED04710810088216 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-1 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 (2)
- EUDAMED 7eedbbf7-4483-41fe-8fea-63af8c07fce2 61 fields · synced Aug 3, 2026
- EUDAMED 39b2859d-884b-494a-ace9-ede449f26580 61 fields · synced May 17, 2026