Jednorázová rouška Balerina BFE99
by Balerina-Czech, s.r.o. 70 variants
Ref 8594205376692Model BFE99
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 | Number859420537BFE99CA 08594205376692 | Date19 Jan 2026 | StatusActive |
Certificates
No certifier 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- Withdrawn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
- Model / Reference
- BFE99, 8594205376692
- Primary DI / UDI-DI
- 08594205376692
- Basic UDI-DI
- 859420537BFE99CA
- Direct Marketing DI
- 08594205376692
- EMDN Code
- T020604 Medical use face masks, type II and iir
- Device Class
- Class I
- EU market of registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000050806
Other devices from Balerina-Czech, s.r.o.
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