Respirator Balerina PFHM931
by Balerina-Czech, s.r.o. EUDAMED
Active
Ref 8594205374643Model PFHM931
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number859420537PFHM931R8 | Date12 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- PFHM931, 8594205374643
- Primary DI / UDI-DI
- 08594205374643
- Basic UDI-DI
- 859420537PFHM931R8
- Direct Marketing DI
- 08594205374643
- EMDN Code
- T020699 Medical use face masks (excluding personal protective equipment - PPE) - other
- Device Class
- Class I
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000050806
Other devices from Balerina-Czech, s.r.o.
Properties
Show 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