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TRUS Biopsy Kit

by Geotek Medikal Ve Saglik Hizmetleri Tic.san.ltd.sti Türkiye EUDAMED

Ref GTR A11-RModel TRUS Biopsy Kit

EMDN A010299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869915834GTRZ8 Basic UDI-DIDate25 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
TRUS Biopsy Kit, GTR A11-R
Primary DI / UDI-DI
08681672056704
Basic UDI-DI
869915834GTRZ8
EMDN Code
A010299 Biopsy needles and kits - other
Device Class
Class IIa
Medical Purpose
Used for USG guided Transrectal Prostate Biopsy for diagnosis.

Manufacturer details

EUDAMED SRN
TR-PR-000039085

Properties & raw data

Show properties, registry sources and raw records
  • Sterile

Sources (1)

  • EUDAMED 2150768f-bf7d-4ad6-aa0c-58371f918c9c 61 fields · synced 22 Oct 2026