Identity
- Trade Name
- OM-2 Mask, Adult EUDAMEDOM-2 Mask, Adult w/Tubing EUDAMED
- Device Name
- Disposable Oxygen therapy EUDAMEDDisposable Mask EUDAMED
- Model / Reference
- AO0086 EUDAMEDAO0084 EUDAMEDAO0152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980102769 EUDAMED06923980105791 EUDAMED06923980110917 EUDAMED
- Basic UDI-DI
- 69239801ND2MAPJ EUDAMED69239801ND2KAPC EUDAMED69239801ND2MFPU EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMEDR03010206 MASKS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 (Xiamen) 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 | 69239801ND2MAPJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED a869af8d-db4f-4f3a-9e1a-7287a89e9074 61 fields · synced Jul 21, 2026
- EUDAMED e96c337b-ccd0-4430-8077-a8d55aac39a2 61 fields · synced May 17, 2026
- EUDAMED 9a34dbdc-3c0a-402f-9a8f-a137abe4f95c 61 fields · synced May 18, 2026