Bergamot Face Mask 3 Ply, Earloop
by Bergamot Sdn Bhd Malaysia EUDAMED
Ref B0501Model Face Mask EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number9555904FMYB | Date15 Dec 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Face Mask
- Model / Reference
- Face Mask, B0501
- Primary DI / UDI-DI
- 09555904300097
- Basic UDI-DI
- 9555904FMYB
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- MY-MF-000004005
- Authorised representative
- ASAP Innovations Ltd. IE-AR-000002548
Other devices from Bergamot Sdn Bhd
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED ca43bae5-9dec-49c4-8c16-d9bb63be051f