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Amed

by Karex Industries Sdn. Bhd. Malaysia EUDAMED

Ref KX07

EMDN Z11040185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-29556564093705 Basic UDI-DIDate11 Aug 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 24 Oct 2026

Device Name
Non-Sterile Natural Rubber Latex Protective Transducer Covers
Model / Reference
KX07
Primary DI / UDI-DI
29556564093705
Basic UDI-DI
B-29556564093705
EMDN Code
Z11040185 Ultrasound scanners - consumables
Device Class
Class IIa
Market of Registration
Poland

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 9f0a4879-e3ae-44c8-a719-86b6c50bbe87 61 fields · synced 24 Oct 2026