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Gyneas Probe Cover

by Karex Industries Sdn. Bhd.

Ref CS-018-06-PC, KX-07

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number9556564-NSPC-WH Basic UDI-DI 09556564086796UDI-DIDate6 May 2025RegisteredStatusActive
European UnionCE/MDR Number9556564-NSPC-WH Basic UDI-DI 09556564086796UDI-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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Trade Name
Gyneas Probe Cover
Gyneas
Device Name
Non-sterile Natural Rubber Latex Protective Transducer Covers
Model / Reference
CS-018-06-PC, KX-07
Primary DI / UDI-DI
09556564086796
Basic UDI-DI
9556564-NSPC-WH, B-09556564086796
EMDN Code
Z11040185 Ultrasound scanners - consumables
Device Class
Class IIa
EU market of registration
France

Manufacturer details

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

From the manufacturer

Manufacturer's product page: e-Brochure

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