Identity
- Trade Name
- Disposable Medical Mask EUDAMED
- Device Name
- Disposable Medical Mask (Non-sterile) EUDAMED
- Model / Reference
- L53392 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975706483171 EUDAMED
- Basic UDI-DI
- 697570648108NB EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Bestreat Safety & First Aid Solution 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 | 697570648108NB | Class I | Active |
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Manufacturer
- Manufacturer
- Bestreat Safety & First Aid Solution Co., Ltd.
- EUDAMED SRN
- CN-MF-000029564
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 6cd28953-9076-469f-8c91-900e9e4c4857 61 fields · synced Oct 6, 2026