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OnSight™ - Vitamin B12 Quantitative Test

by Affimedix, Inc. United States EUDAMED

Ref 665-25-DB EMDN W0102070204

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850082432219 Basic UDI-DIDate5 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
665-25-DB
Primary DI / UDI-DI
00850082432219
Basic UDI-DI
B-00850082432219
EMDN Code
W0102070204 Vitamin b12
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 c394ec81-15d1-4510-b21c-a70d8e3d9e72 61 fields · synced 25 Oct 2026