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One Touch Lights Intimate Gel 75 ml

by Tecnilatex, S.A.U.

Ref 400308

Active European Union

CE MDR

Valid until

20 Oct 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier ISTITUTO SUPERIORE DI SANITA'

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 NumberCSQ0041260126 Date21 Oct 2026IssuedStatusActive expires 20 Oct 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • CSQ0041260126 Active Supplemented

    Quality management system EU MDR

    Issued
    21 Oct 2026
    Expires
    20 Oct 2031
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Water based intimate lubricating gel
Model / Reference
400308
Primary DI / UDI-DI
08447289000383
Basic UDI-DI
8447289LBWB00132
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb
EU market of registration
Latvia

Manufacturer details

EUDAMED SRN
ES-MF-000000284

Other devices from Tecnilatex, S.A.U.

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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