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Disposable medical face mask
EUDAMEDClass I (EU MDR)
Ref LY- FM02Model LY- FM00
Identity
- Trade Name
- Disposable medical face mask EUDAMED
- Device Name
- Disposable medical face mask EUDAMED
- Model / Reference
- LY- FM00 EUDAMEDLY- FM02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975394400023 EUDAMED
- Basic UDI-DI
- 697539440LYFM01VK 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
Disposable medical face mask by Linye Health Tech(ningbo)co., Ltd — Class I — CE/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 | 697539440LYFM01VK | Class I | Active |
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Manufacturer
- Manufacturer
- Linye Health Tech(ningbo)co., Ltd
- EUDAMED SRN
- CN-MF-000024232
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (1)
- EUDAMED 1d60abf8-12f0-42cc-a487-949bfd6f8c03 61 fields · synced Oct 7, 2026