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Face mask , 2pcs/Unit, 10pcs/transparent zip bag
EUDAMEDClass I (EU MDR)
Ref 46235
Identity
- Trade Name
- Face mask , 2pcs/Unit, 10pcs/transparent zip bag EUDAMED
- Device Name
- Disposable Medical Mask EUDAMED
- Model / Reference
- 46235 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951454763451 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
- 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
Face mask , 2pcs/Unit, 10pcs/transparent zip bag 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 2fe20d6e-d75a-4540-8ac7-527c099e1f3a 61 fields · synced Oct 6, 2026