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Pasante Delay Infinity 12

by Karex Industries Sdn. Bhd. Malaysia EUDAMED

Ref R1223KModel P53S

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-09556564087007 Basic UDI-DIDate16 Oct 2026RegisteredStatusActive

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 23 Oct 2026

Model / Reference
P53S, R1223K
Primary DI / UDI-DI
09556564087007
Basic UDI-DI
B-09556564087007
EMDN Code
U110101 Condoms
Device Class
Class III
Market of Registration
Czechia

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 09556564087007|B-09556564087007 61 fields · synced 23 Oct 2026