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Medline KX06 Sterile, Unlubricated

by Karex Industries Sdn. Bhd.

Ref ICE28295P

Active European Union

CE MDR CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number9556564-SPIPC-YF Basic UDI-DI 29556564089708UDI-DIDate4 Mar 2026RegisteredStatusActive
European UnionCE/MDR Number9556564-SPIPC-YF Basic UDI-DI 29556564089708UDI-DIDate4 Mar 2026RegisteredStatusActive

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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
Medline KX06 Sterile, Unlubricated
Medline
Device Name
Sterile Synthetic Polyisoprene Latex Protective Transducer Covers
Model / Reference
ICE28295P
Primary DI / UDI-DI
29556564089708
Basic UDI-DI
9556564-SPIPC-YF, B-29556564089708
EMDN Code
Z11040185 Ultrasound scanners - consumables
Device Class
Class IIa
EU market of registration
Netherlands
France

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

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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