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Tissue-Tek Genie® Controller System

by Sakura Finetek USA, Inc EUDAMED

Active European Union

Ref 0008008-01

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number06152338226JA Basic UDI-DIDate13 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Tissue-Tek Genie® Accessories (Auxiliary Products)
Model / Reference
0008008-01
Primary DI / UDI-DI
00615233002907
Basic UDI-DI
06152338226JA
EMDN Code
W0202059002 Automated slide stainers
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000022208
Authorised representative
Sakura Finetek Europe B.V. NL-AR-000007853

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Properties

  • Professional Testing

Other properties (10)

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