Identity
- Trade Name
- Disposable medical mask EUDAMEDDisposable Medical Mask(Non-sterile) EUDAMED
- Device Name
- Disposable Medical Mask (Non-sterile) EUDAMED
- Model / Reference
- 4002 EUDAMEDL53392 EUDAMED4001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975706480507 EUDAMED06975706483171 EUDAMED06975706484017 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
- Poland EUDAMEDBelgium EUDAMEDGermany 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 — 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 (3)
- EUDAMED df7fae94-fc0d-461d-8d22-6fbb3ed2ff7f 61 fields · synced Oct 6, 2026
- EUDAMED 6cd28953-9076-469f-8c91-900e9e4c4857 61 fields · synced May 17, 2026
- EUDAMED 9f60070e-4c69-4bb4-90af-9ef39352ce42 61 fields · synced May 18, 2026