Skip to content

ChromoQuant Optima 13

by Cybergene AB Sweden EUDAMED

Ref 514.601-26

EMDN W0106010304

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07350041434580 Basic UDI-DIDate11 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
ChromoQuant Optima 13
Model / Reference
514.601-26
Primary DI / UDI-DI
07350041434580
Basic UDI-DI
B-07350041434580
EMDN Code
W0106010304 Pätau syndrome
Device Class
Class IVD General
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000054343

Other devices from Cybergene AB

See all devices from Cybergene AB →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 03ba2279-e100-42f3-abe3-3d7af793f33c 61 fields · synced 24 Oct 2026