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Sickle SCAN Test

by BioMedomics United States EUDAMED

Ref CXJ020

EMDN W0106010109

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-USMF000054278BMCXJ020HP Basic UDI-DIDate14 May 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 23 Oct 2026

Model / Reference
CXJ020
Primary DI / UDI-DI
D-USMF000054278BMCXJ020HP
Basic UDI-DI
B-USMF000054278BMCXJ020HP
EMDN Code
W0106010109 Sickle cell anemia
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000054278
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

From the manufacturer

Manufacturer's product page: Sickle SCAN

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 0067d1b8-194a-4829-89c4-a9c4c29964aa 61 fields · synced 23 Oct 2026