Identity
- Trade Name
- Disposable medical mask EUDAMED
- Device Name
- Disposable Medical Mask EUDAMED
- Model / Reference
- F108-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454794851 EUDAMED
- Basic UDI-DI
- 69514547309VG EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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 (1)
- EUDAMED c93c5c2f-e67e-4b13-a26f-bfaf450c0594 61 fields · synced Jun 18, 2026