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MEDIWARE Non-Sterile, Unlubricated KX07

by Karex Industries Sdn. Bhd. EUDAMED

Active European Union

Ref H5 1340

Overview

The MEDIWARE Non-Sterile, Unlubricated KX07 is a Class IIa medical device designed to provide accurate and reliable measurements of anatomical dimensions. This innovative device features a non-sterile natural rubber latex protective transducer cover that can be used for various clinical applications, including obstetrics, urology, and cardiology.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9556564-NSPC-WH Basic UDI-DIDate6 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Non-sterile Natural Rubber Latex Protective Transducer Covers
Model / Reference
H5 1340
Primary DI / UDI-DI
29556564101189
Basic UDI-DI
9556564-NSPC-WH
EMDN Code
Z11040185 Ultrasound scanners - consumables
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
MY-MF-000001247
Authorised representative
Advena Limited MT-AR-000000234

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Properties

  • 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