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oxygen mask
EUDAMEDClass IIa (EU MDR)
Ref EC23010104Model Non-rebreathing Adult Elongated
Identity
- Trade Name
- oxygen mask EUDAMED
- Device Name
- oxygen mask EUDAMED
- Model / Reference
- Non-rebreathing Adult Elongated EUDAMEDEC23010104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941951007325 EUDAMED
- Basic UDI-DI
- B-06941951007325 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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 Guangdong Ecan Medical 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-06941951007325 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Ecan Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000020906
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 1e220ada-3188-4f67-b78e-1378893c5d2b 61 fields · synced Jun 18, 2026