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SAX™ Super Max

by Karex Industries Sdn. Bhd. Malaysia EUDAMED

Ref 900

EMDN U110101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9556564-NMCM-U4 Basic UDI-DIDate19 Dec 2022RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Non-sterile, Non-medicated Natural Rubber Latex Male Condoms
Model / Reference
900
Primary DI / UDI-DI
09328951009004
Basic UDI-DI
9556564-NMCM-U4
EMDN Code
U110101 Condoms
Device Class
Class IIb

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 (1)

  • EUDAMED 7764d4e0-ce1c-4d0e-adba-12a1c676f291 61 fields · synced 24 Oct 2026