Respirator Balerina PFHM722, economy edition
by Balerina-Czech, s.r.o. 4 variants
Ref 8594205371291, 8594205370034, 8594205371277, 8594205370010, 8594205370041, 8594205371284Model PFHM722
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 | Number859420537PFHM722QV | Date9 Dec 2025 | 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- Withdrawn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
- PFHM722, 8594205371291, 8594205370034, 8594205371277, 8594205370010, 8594205370041, 8594205371284
- Primary DI / UDI-DI
- 08594205371291, 08594205370034, 08594205371277, 08594205370010, 08594205370041, 08594205371284
- Basic UDI-DI
- 859420537PFHM722QV
- Direct Marketing DI
- 085942053712910859420537003408594205371277085942053700100859420537004108594205371284
- EMDN Code
- T020699 Medical use face masks (excluding personal protective equipment - PPE) - other
- 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