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C-3022-40

by ZytoVision GmbH EUDAMED

Active European Union

Ref C-3022-40Model ZytoDot 2C SPEC ERBB2/CEN 17 Probe Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4250380N467W Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
ZytoDot 2C SPEC ERBB2/CEN 17 Probe Kit, C-3022-40
Primary DI / UDI-DI
04250380300221
Basic UDI-DI
4250380N467W
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000024390

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Properties

Show properties
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No