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Adult oxygen mask medium conc.
EUDAMEDClass IIa (EU MDR)
Ref XTA0048Ref XTA0023
Identity
- Trade Name
- Adult oxygen mask medium conc. EUDAMED
- Device Name
- Disposable Oxygen therapy EUDAMED
- Model / Reference
- XTA0048 EUDAMEDXTA0023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980110610 EUDAMED06923980110603 EUDAMED
- Basic UDI-DI
- 69239801ND2MAPJ EUDAMED
- EMDN Code
- R03010205 TRACHEOSTOMY O2 SUPPLIERS 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 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 (2)
- EUDAMED d2e3a829-b5b5-48d7-b23e-696eb50cc724 61 fields · synced Jul 9, 2026
- EUDAMED 2fe866f6-c1db-49e3-9782-aded598401f4 61 fields · synced May 18, 2026