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Disposable Air Cushion Face Masks
EUDAMEDClass IIa (EU MDR)
Ref 6185Model Adult type
Identity
- Trade Name
- Disposable Air Cushion Face Masks EUDAMED
- Device Name
- Disposable Air Cushion Face Masks EUDAMED
- Model / Reference
- Adult type EUDAMED6185 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230161850 EUDAMED
- Basic UDI-DI
- 69492301MZMZA046H EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE 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
Disposable Air Cushion Face 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 | 69492301MZMZA046H | 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 dbf08a4b-980c-4d18-8442-f5c77bd6bc32 61 fields · synced Jul 19, 2026