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Gyneas

by Karex Industries Sdn. Bhd. EUDAMED

Active European Union

Ref KX-07, CS-018-02-PC

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-09556564086956 Basic UDI-DIDate10 Aug 2023RegisteredStatusActive
European UnionCE/MDD NumberB-09556564086956 Basic UDI-DIDate10 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR, CE/MDD Active

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.

Specification

EUDAMED

Trade Name
Gyneas
Gyneas Probe Cover
Device Name
Non-Sterile Natural Rubber Latex Protective Transducer Covers
Model / Reference
KX-07, CS-018-02-PC
Primary DI / UDI-DI
09556564086956
Basic UDI-DI
B-09556564086956, 9556564-NSPC-WH
EMDN Code
Z11040185 Ultrasound scanners - consumables
Device Class
Class IIa
Market of Registration
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

  • 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