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OM-3 HiO2 Mask, Child w/Tubing, PVC Bag
EUDAMEDClass IIa (EU MDR)
Ref AO0097Model (D) Oxygen Therapy
Identity
- Trade Name
- OM-3 HiO2 Mask, Child w/Tubing, PVC Bag EUDAMED
- Device Name
- Disposable Oxygen therapy EUDAMEDHi-Oxygen Mask EUDAMED
- Model / Reference
- AO0097 EUDAMED(D) Oxygen Therapy EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980106040 EUDAMED04710810081934 EUDAMED
- Basic UDI-DI
- 69239801ND2MFPU EUDAMED471081008NND378 EUDAMED
- EMDN Code
- R03010206 MASKS WITH RESERVOIR EUDAMEDR03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands 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 HiO2 Mask, Child w/Tubing, PVC Bag 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 | 69239801ND2MFPU | 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 (2)
- EUDAMED b724d482-5ed3-46c0-ae2c-42af73c813dd 61 fields · synced Oct 6, 2026
- EUDAMED b5954f3e-b1d3-4fea-9312-23dc35583879 61 fields · synced May 19, 2026