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GynTect

by Epitype GmbH EUDAMED

Active European Union

Ref GT003-10

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number426076785GYNTECTYM Basic UDI-DIDate30 May 2022RegisteredStatusActive
European UnionCE/IVDR Number426076785GYNTECTYM Basic UDI-DIDate30 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR 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

Model / Reference
GT003-10
Primary DI / UDI-DI
04260767851116
Basic UDI-DI
426076785GYNTECTYM, B-04260767851116
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000024421

Other devices from Epitype GmbH

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No