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Paediatric oxygen mask medium conc.
EUDAMEDClass IIa (EU MDR)
Ref XTA0049Ref XTA0047Ref XTA0022
Identity
- Trade Name
- Paediatric oxygen mask medium conc. EUDAMEDPAEDIATRIC OXYGEN MASK MEDIUM EUDAMED
- Device Name
- Disposable Oxygen therapy EUDAMEDDisposable Mask EUDAMED
- Model / Reference
- XTA0049 EUDAMEDXTA0047 EUDAMEDXTA0022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980110825 EUDAMED06923980109690 EUDAMED06923980110849 EUDAMED
- Basic UDI-DI
- 69239801ND2MAPJ EUDAMED69239801ND2KAPC EUDAMED
- EMDN Code
- R03010205 TRACHEOSTOMY O2 SUPPLIERS EUDAMEDR03010201 AIR/OXYGEN MASKS 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
Paediatric oxygen mask medium conc. 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 24891196-2879-4e20-9b14-3066d774a3ba 61 fields · synced Aug 2, 2026
- EUDAMED 702fedbe-c9d9-425b-8f08-6725a3f90f67 61 fields · synced May 18, 2026
- EUDAMED 4b7ad208-add2-4c0f-b1a7-1f9ef8174af5 61 fields · synced May 19, 2026