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Oxygen Mask
EUDAMEDClass IIa (EU MDR)
Ref 800-20001-ENModel 800-20001Ref 800-10001-ENModel 800-10001
Identity
- Trade Name
- Oxygen Mask EUDAMED
- Device Name
- Oxygen Mask EUDAMED
- Model / Reference
- 800-20001 EUDAMED800-20001-EN EUDAMED800-10001 EUDAMED800-10001-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719894386126 EUDAMED04719894383293 EUDAMED
- Basic UDI-DI
- B-04719894386126 EUDAMEDB-04719894383293 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oxygen Mask by VADI Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719894386126 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VADI Medical Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000022930
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED 753755a3-f520-4ff8-9cbb-c7ea5daea0bb 61 fields · synced Jul 21, 2026
- EUDAMED 15fb17a3-811a-4d89-8561-ecb37d410300 61 fields · synced May 18, 2026