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Adult Oxygen Mask High-Concentration
EUDAMEDClass IIa (EU MDR)
Ref XTA0050Ref XTA0054
Identity
- Trade Name
- ADULT OXYGEN MASK HIGH-CONCENTRATION EUDAMED
- Device Name
- Disposable Oxygen therapy EUDAMED
- Model / Reference
- XTA0050 EUDAMEDXTA0054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980110818 EUDAMED06923980110634 EUDAMED
- Basic UDI-DI
- 69239801ND2MFPU EUDAMED
- EMDN Code
- R03010206 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
Adult Oxygen Mask High-Concentration 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 d508545c-8a3c-4106-bf92-d17e044f0452 61 fields · synced Jul 25, 2026
- EUDAMED 72626fd4-ae61-46b7-b05a-49444f5eb42c 61 fields · synced May 17, 2026