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GYNI ™ Scanner

by GynTools LTD Israel EUDAMED

Ref GTDS0000

EMDN W02029099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-72900184696062W Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
GTDS0000
Primary DI / UDI-DI
D-72900184696062W
Basic UDI-DI
B-72900184696062W
EMDN Code
W02029099 Various hematology / histology / cytology instruments - other
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
IL-MF-000008020
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from GynTools LTD

Properties & raw data

Show properties, registry sources and raw records
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 6b4a6b70-1884-43f9-a43f-a41e0f8532f9 61 fields · synced 24 Oct 2026