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FFP3 NR Medical Particle Filtering Half Mask –5pcs

by ROYAX, s.r.o.

Ref R-DP-R-FFP3-01Model FFP3 NR Type IIR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number859420820FFP3GX Basic UDI-DI Date23 Jun 2026RegisteredStatusActive

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  • Withdrawn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

Trade Name
FFP3 NR Medical Particle Filtering Half Mask –5pcs
FFP3 NR Medical Particle Filtering Half Mask
Device Name
FFP3 NR Medical Particle Filtering Half Mask Type IIR
Model / Reference
FFP3 NR Type IIR, R-DP-R-FFP3-01
Primary DI / UDI-DI
08594208200529, 08594208200512
Basic UDI-DI
859420820FFP3GX
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-000020709

Other devices from ROYAX, s.r.o.

See all devices from ROYAX, 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