Identity
- Trade Name
- PAEDIATRIC OXYGEN MASK HIGH EUDAMED
- Device Name
- Disposable Oxygen therapy EUDAMED
- Model / Reference
- XTA0072 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980110726 EUDAMED
- Basic UDI-DI
- 69239801ND2MFPU 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
Our PAEDIATRIC OXYGEN MASK HIGH device provides portable, disposable oxygen therapy for pediatric patients. Made by GaleMed (Xiamen) Co., Ltd., this oxygen mask is designed for use in emergency situations or as a supplement to conventional medical treatment.
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 (1)
- EUDAMED b6ffe788-8b75-465f-bb1f-bbc67b91f545 61 fields · synced Jul 24, 2026