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GYNI ™ smart sampler

by GynTools LTD Israel EUDAMED

Ref GTVD0000

EMDN A1101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7290018469GTVD0000VV Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
GTVD0000
Primary DI / UDI-DI
07290018469408
Basic UDI-DI
7290018469GTVD0000VV
EMDN Code
A1101 Sample collection neutral swabs
Device Class
Class I
Market of Registration
Belgium

Manufacturer details

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

Related devices

Category: General-purpose absorbent tip applicator/swab, single-use

Other devices from GynTools LTD

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • 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

Sources (1)

  • EUDAMED 58984941-c0c2-4cfa-b4c3-c4283baa498d 61 fields · synced 24 Oct 2026