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Mascarilla Quirúrgica FactorPharma tipo IIR

by Factor Pharma Products S.L. 2 variants

Ref FPIIRN-G01_GOMAS NEGRAModel Mascarilla quirúrgica Tipo 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8437024751FP_MASKSCL Basic UDI-DI 08437024751021UDI-DIDate12 Jul 2022RegisteredStatusActive

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  • Withdrawn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
Mascarilla quirúrgica Tipo IIR, FPIIRN-G01_GOMAS NEGRA
Primary DI / UDI-DI
08437024751021
Basic UDI-DI
8437024751FP_MASKSCL
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000024695

Other devices from Factor Pharma Products S.L.

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