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Single-use medical face mask
EUDAMEDClass I (EU MDR)
Ref 762030-NModel FN-FM0101
Identity
- Trade Name
- Single-use medical face mask EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- FN-FM0101 EUDAMED762030-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973911690063 EUDAMED
- Basic UDI-DI
- 697391169FM0101E9 EUDAMED
- Unit of Use DI
- 06973911693538 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Single-use medical face mask by Finess Healthcare 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 | 697391169FM0101E9 | Class I | Active |
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Manufacturer
- Manufacturer
- Finess Healthcare Group Co., Ltd
- EUDAMED SRN
- CN-MF-000004124
- Authorised Representative
- Zoustech S.L. ES-AR-000002008
Sources (1)
- EUDAMED 5d3eae04-5d00-4fe3-ae85-152220fc3bca 61 fields · synced Oct 7, 2026