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Face Masks For Single Use
EUDAMEDClass I (EU MDR)
Ref 6078Model Type II、Type IIR
Identity
- Trade Name
- Face Masks For Single Use EUDAMED
- Device Name
- Face Masks For Single Use EUDAMED
- Model / Reference
- Type II、Type IIR EUDAMED6078 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949230160785 EUDAMED
- Basic UDI-DI
- 69492301YCXKZ027T EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I 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
Face Masks For Single Use by Jiangxi Yikang Medical Instrument Group Co., Ltd. — Class I — 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 | 69492301YCXKZ027T | Class I | 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 f21e7b78-96ba-4b46-9967-546f119a02de 61 fields · synced Aug 3, 2026