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Respirator Balerina PFHM722, economy edition

by Balerina-Czech, s.r.o. 4 variants

Ref 8594205360011Model PFHM722

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859420537PFHM722QV Basic UDI-DI 08594205360011UDI-DIDate9 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
PFHM722, 8594205360011
Primary DI / UDI-DI
08594205360011
Basic UDI-DI
859420537PFHM722QV
Direct Marketing DI
08594205360011
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.

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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