Identity
- Trade Name
- CPR Pocket Mask EUDAMED
- Device Name
- Resuscitation Face Shield EUDAMED
- Model / Reference
- 600.MX.8200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975706481160 EUDAMED
- Basic UDI-DI
- 697570648107N9 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
CPR Pocket 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 | 697570648107N9 | 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 29f2a715-025f-4224-b3c2-64388dd1f63d 61 fields · synced Jun 18, 2026