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Face masks with elastic strap
EUDAMEDClass I (EU MDR)
Ref FN-FM0101030106Model FN-FM0101
Identity
- Trade Name
- Face masks with elastic strap EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- FN-FM0101 EUDAMEDFN-FM0101030106 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973911690223 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
- Netherlands 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
Face masks with elastic strap 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 edb12ae2-dce8-440d-81f5-b4dbc2cfc4b1 61 fields · synced Jul 9, 2026