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MyOne

by Karex Industries Sdn. Bhd. Malaysia EUDAMED

Ref P47S - S66 (47E) XUT

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-726893510876K6 Basic UDI-DIDate5 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Non-sterile Non-medicated Natural Rubber Latex Male Condom
Model / Reference
P47S - S66 (47E) XUT
Primary DI / UDI-DI
D-726893510876K6
Basic UDI-DI
B-726893510876K6
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 8d9a7211-f6c1-49ba-b239-c08f05d71c8c 61 fields · synced 22 Oct 2026