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OnSight™ Ferritin Quantitative Test

by Affimedix, Inc. United States EUDAMED

Ref 670-25-DB

EMDN W0102070102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850082432080 Basic UDI-DIDate3 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

Model / Reference
670-25-DB
Primary DI / UDI-DI
00850082432080
Basic UDI-DI
B-00850082432080
EMDN Code
W0102070102 Ferritin
Device Class
Class IVD General
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000053178
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Affimedix, Inc.

See all devices from Affimedix, Inc. →

Properties & raw data

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

Sources (1)

  • EUDAMED b964d94c-0366-48e9-8caa-5523b56cb8f3 61 fields · synced 24 Oct 2026