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OnSight™ Testosterone Quantitative Test

by Affimedix, Inc. United States EUDAMED

Ref 650-25-DB

EMDN W01021699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850082432110 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 22 Oct 2026

Model / Reference
650-25-DB
Primary DI / UDI-DI
00850082432110
Basic UDI-DI
B-00850082432110
EMDN Code
W01021699 Rapid tests & point of care - immunochemistry - other
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 a10ae38a-a628-468a-abce-5f40cc93180c 61 fields · synced 22 Oct 2026