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MEDIWARE Non-Sterile, Unlubricated KX07

by Karex Industries Sdn. Bhd. 2 variants

Ref H5 1320

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Overview

The MEDIWARE Non-Sterile, Unlubricated KX07 medical device is a high-quality, non-sterile natural rubber latex protective transducer covers designed for use in various healthcare applications. Featuring Class IIa sterility, this device provides an effective barrier against microorganisms and allergens, making it ideal for applications where sterility is crucial.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number9556564-NSPC-WH Basic UDI-DI 29556564101202UDI-DIDate6 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
H5 1320
Primary DI / UDI-DI
29556564101202
Basic UDI-DI
9556564-NSPC-WH
EMDN Code
Z11040185 Ultrasound scanners - consumables
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

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

Other devices from Karex Industries Sdn. Bhd.

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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