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SOFT Naturel Gel

by Karex Industries Sdn. Bhd. EUDAMED

Active European Union

Ref C1530DBEV

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09556564088288 Basic UDI-DIDate15 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Non-sterile, Warming, Cooling, Regular Plain Water-based Lubricant & Silicone Oil-based Lubricant
Model / Reference
C1530DBEV
Primary DI / UDI-DI
09556564088288
Basic UDI-DI
B-09556564088288
EMDN Code
U0803 Vaginal devices in the form of solutions/creams/ova/tablets
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
MY-MF-000001247
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Karex Industries Sdn. Bhd.

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Properties

Show properties
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No