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Surgical Face Mask
EUDAMEDClass I (EU MDR)
Ref FN-FM0101030601Model FN-FM0101Ref FN-FM0101030106Ref FN-FM0101030201Ref FN-FM0101030401
Identity
- Trade Name
- Surgical Face Mask EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- FN-FM0101 EUDAMEDFN-FM0101030601 EUDAMEDFN-FM0101030106 EUDAMEDFN-FM0101030201 EUDAMEDFN-FM0101030401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973911691190 EUDAMED06973911691114 EUDAMED06973911691138 EUDAMED06973911691176 EUDAMED
- Basic UDI-DI
- 697391169FM0101E9 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
Surgical 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 (4)
- EUDAMED bbde7f20-3a1a-4f1f-b5d7-2f231425512b 61 fields · synced Oct 6, 2026
- EUDAMED 27b09ea3-6146-43e6-804a-f0b30d545af3 61 fields · synced May 18, 2026
- EUDAMED 7418eb43-60dd-4ce7-b421-210a7b38e7ee 61 fields · synced May 18, 2026
- EUDAMED ce56eb5e-dc28-472a-9e23-facac19b1d6a 61 fields · synced May 18, 2026