Face-masks, type 1
by Bestreat Safety & First Aid Solution Co., Ltd.
Ref 4001-P2
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697570648108NB | Date27 Dec 2025 | StatusActive |
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Disposable Medical Mask (Non-sterile)
- Model / Reference
- 4001-P2
- Primary DI / UDI-DI
- 06975706483911
- Basic UDI-DI
- 697570648108NB
- EMDN Code
- T020699 Medical use face masks (excluding personal protective equipment - PPE) - other
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000029564
- Authorised representative
- MedPath GmbH DE-AR-000000087
Other devices from Bestreat Safety & First Aid Solution Co., Ltd.
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No