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CONTROL LUB GEL Infinity EN-IT

by Tecnilatex, S.A.U.

Ref 400312

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 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

    Certifier
    ISTITUTO SUPERIORE DI SANITA' 0373
    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  • Withdrawn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
Silicone based intimate lubricating gel
Model / Reference
400312
Primary DI / UDI-DI
08447289000352
Basic UDI-DI
8447289LBSB001ZK
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIb
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
ES-MF-000000284

Other devices from Tecnilatex, S.A.U.

See all devices from Tecnilatex, S.A.U. →

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