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Gelclair

by Biokosmes s.r.l. 9 variants

Ref 051Model 0BIO4I02ED03

Active European Union

CE MDR

Valid until

11 Apr 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Eurofins Product Testing Italy S.r.l.

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 Number805596029051FF Basic UDI-DI 08055960290512UDI-DIDate23 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.24/5443 Active

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    12 Apr 2024
    Expires
    11 Apr 2029

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
0BIO4I02ED03, 051
Primary DI / UDI-DI
08055960290512
Basic UDI-DI
805596029051FF
EMDN Code
M9002 Protective devices, lubricants and soothing devices (sprays, gels, fluids and creams)
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
IT-MF-000017206

Other devices from Biokosmes s.r.l.

See all devices from Biokosmes s.r.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