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Disposable sterile medical mask

by Guangdong Kingfa Sci. & Tech. Co., Ltd. 8 variants

Ref KF-B P08(WK-BD-EO)Model KF-B P01(EN-EO) KF-B P01(II-EO) KF-B P01(WK-EO) KF-B P08(WK-EO) KF-B P09(WK-EO) KF-B P01(WK-BD-EO) KF-B P08(WK-BD-EO) KF-B P09(WK-BD-EO)

Active European Union

CE MDR

Valid until

30 Mar 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCN26/00002176 Date30 Mar 2026IssuedStatusActive expires 30 Mar 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CN26/00002176 Active

    Quality assurance EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    30 Mar 2026
    Expires
    30 Mar 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Disposable sterile medical mask
Model / Reference
KF-B P01(EN-EO) KF-B P01(II-EO) KF-B P01(WK-EO) KF-B P08(WK-EO) KF-B P09(WK-EO) KF-B P01(WK-BD-EO) KF-B P08(WK-BD-EO) KF-B P09(WK-BD-EO), KF-B P08(WK-BD-EO)
Primary DI / UDI-DI
16976739564209
Basic UDI-DI
697673956KF-BSU
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009520
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from Guangdong Kingfa Sci. & Tech. Co., Ltd.

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Properties

  • Sterile

Other properties (12)

  • 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