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Optilite® Alpha-2-Macroglobulin Urine Control Pack

by The Binding Site Group Ltd EUDAMED

Active European Union

Ref NQ039.U.OPTModel NK039.U.OPT

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5051700NK039.U.OPTS8 Basic UDI-DIDate28 Jan 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Optilite® Alpha-2-Macroglobulin Urine Kit
Model / Reference
NK039.U.OPT, NQ039.U.OPT
Primary DI / UDI-DI
05051700019354
Basic UDI-DI
5051700NK039.U.OPTS8
EMDN Code
W0102019003 A2-macroglobulin
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
UK-MF-000036707
Authorised representative
The Binding Site Ireland Limited IE-AR-000034426

Other devices from The Binding Site Group Ltd

See all devices from The Binding Site Group Ltd →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No