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OM-3 Mask, Adult w/Tubing
EUDAMEDClass IIa (EU MDR)
Ref AO0154Model (D) Oxygen TherapyRef AO0083
Identity
- Trade Name
- OM-3 Mask, Adult w/Tubing EUDAMED
- Device Name
- Oxygen Mask EUDAMED
- Model / Reference
- (D) Oxygen Therapy EUDAMEDAO0154 EUDAMEDAO0083 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810083389 EUDAMED04710810111198 EUDAMED
- Basic UDI-DI
- 471081008NND276 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-3 Mask, Adult w/Tubing 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 fa613643-8b7d-4c6d-a951-d79ebba88817 61 fields · synced Oct 6, 2026
- EUDAMED c3013ea8-6d70-4e6a-accc-5f0aee7811bf 61 fields · synced May 18, 2026