Skip to content

ONE Vanish

by Karex Industries Sdn. Bhd. EUDAMED

Active European Union

Ref P53S XUT

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-726893115019GZ Basic UDI-DIDate13 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Non-sterile Non-medicated Natural Rubber Latex Male Condom
Model / Reference
P53S XUT
Primary DI / UDI-DI
D-726893115019GZ
Basic UDI-DI
B-726893115019GZ
EMDN Code
U110101 Condoms
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

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

Other devices from Karex Industries Sdn. Bhd.

See all devices from Karex Industries Sdn. Bhd. →

Properties

  • Contains Latex

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No