Identity
- Trade Name
- Disposable medical mask EUDAMED
- Device Name
- Disposable Medical Mask EUDAMED
- Model / Reference
- F108-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454723240 EUDAMED06951454719960 EUDAMED06951454709558 EUDAMED06951454748120 EUDAMED06951454720645 EUDAMED06951454779360 EUDAMED
- Basic UDI-DI
- 69514547309VG EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMEDH900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDGermany EUDAMEDItaly EUDAMEDFinland 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 mask by Gauke Healthcare 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 | 69514547309VG | Class I | Active |
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Manufacturer
- Manufacturer
- GAUKE Healthcare Co., Ltd
- EUDAMED SRN
- CN-MF-000013784
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (6)
- EUDAMED 8f8e7640-e8d2-48d3-8c6c-914b3808402c 61 fields · synced Oct 6, 2026
- EUDAMED ca4362c2-f3da-4d83-974b-f85c0853ad7d 61 fields · synced May 16, 2026
- EUDAMED 680ddee6-a8b6-407a-913f-fa3f6fa68b0d 61 fields · synced May 17, 2026
- EUDAMED 50acda0e-cfe4-45cf-863b-384a822dbbd5 61 fields · synced May 19, 2026
- EUDAMED 1d78c287-0d92-4812-ba93-6f5edb67c660 61 fields · synced May 19, 2026
- EUDAMED c64a3736-4c53-4b17-878e-09ce0df2ca75 61 fields · synced May 19, 2026