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DNA in situ Hybridization Reagents

by CytoTest Inc. EUDAMED

Active European Union

Ref CT-PACxxxModel DNA FISH Probe Kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CT-PACxxxMQ Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
DNA FISH Probe Kit, CT-PACxxx
Primary DI / UDI-DI
D-CT-PACxxxMQ
Basic UDI-DI
B-CT-PACxxxMQ
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000054699
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from CytoTest Inc.

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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