Identity
- Trade Name
- Oxygen masks EUDAMED
- Device Name
- Oxygen masks EUDAMED
- Model / Reference
- Normal adult type EUDAMED6168 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230161683 EUDAMED
- Basic UDI-DI
- 69492301YQMZA0192 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
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
Oxygen masks by Jiangxi Yikang Medical Instrument Group 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 | 69492301YQMZA0192 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangxi Yikang Medical Instrument Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000030129
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 21b370ac-d5e4-43d8-b27b-a1ae87d734b8 61 fields · synced Jul 10, 2026