← Back to catalogue
OM-2 HiO2 Mask, Child w/Tubing
EUDAMEDClass IIa (EU MDR)
Ref AO0092Model (D) Oxygen TherapyRef AO0094
Identity
- Trade Name
- OM-2 HiO2 Mask, Child w/Tubing EUDAMEDOM-2 HiO2 Mask, Child w/Tubing, PVC Bag EUDAMED
- Device Name
- Hi-Oxygen Mask EUDAMED
- Model / Reference
- (D) Oxygen Therapy EUDAMEDAO0092 EUDAMEDAO0094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810084676 EUDAMED04710810082283 EUDAMED
- Basic UDI-DI
- 471081008NND378 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 HiO2 Mask, Child 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 | 471081008NND378 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c5e403d1-7c84-447e-89fd-d8b422d54390 61 fields · synced Jun 20, 2026
- EUDAMED 8f81c233-4cbb-47b8-88ea-d3c7ecd2c2c1 61 fields · synced May 17, 2026