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HS 5-dye Spectral Calibration Matrix Standard

by Cybergene AB EUDAMED

Active European Union

Ref 701.001-36

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number735004143HS5DJ Basic UDI-DIDate10 Jun 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  • Withdrawn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

Device Name
HS 5-dye Spectral Calibration Matrix Standard
Model / Reference
701.001-36
Primary DI / UDI-DI
07350041433415
Basic UDI-DI
735004143HS5DJ
Direct Marketing DI
07350041433415
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000054343

Other devices from Cybergene AB

See all devices from Cybergene AB →

Properties

Show 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