Respirator Balerina PFHM931
by Balerina-Czech, s.r.o. 104 variants
Ref 8594205375510Model PFHM931
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
The Respirator Balerina PFHM931 is a Class I device that utilizes advanced technology to provide precise control over gas exchange and ventilation. With its reliable performance and minimal maintenance requirements, it has become an industry standard for respiratory support.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number859420537PFHM931R8 08594205375510 | Date12 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- Withdrawn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
- PFHM931, 8594205375510
- Primary DI / UDI-DI
- 08594205375510
- Basic UDI-DI
- 859420537PFHM931R8
- Direct Marketing DI
- 08594205375510
- 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