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Soft Invisible

by Karex Industries Sdn. Bhd. Malaysia EUDAMED

Ref CS-018-76, P53S XUT

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number9556564-NMCM-U4 Basic UDI-DIDate19 Dec 2022RegisteredStatusActive
European UnionCE/MDR Number9556564-NMCM-U4 Basic UDI-DIDate19 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
Non- sterile Non-medicated Natural Rubber Latex Male Condom
Model / Reference
CS-018-76, P53S XUT
Primary DI / UDI-DI
09556564086741
Basic UDI-DI
9556564-NMCM-U4, B-09556564086741
EMDN Code
U110101 Condoms
Device Class
Class IIb
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.

See all devices from Karex Industries Sdn. Bhd. →

Properties & raw data

Show properties, registry sources and raw records
  • Contains Latex
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: 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

Sources (2)

  • EUDAMED 0384dc7c-c2f2-4fb8-b76a-3fdac9f72352 61 fields · synced 22 Oct 2026
  • EUDAMED edb0c481-9adb-4f30-b3c1-2274b82dba27 61 fields · synced 17 May 2026