Skip to content

Optilite® Freelite Mx™ Lambda Free Control Pack

by The Binding Site Group Ltd United Kingdom EUDAMED

Ref NQ018.M.OPTModel LK018.M.OPT EMDN W0102010109

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5051700LK018.M.OPTKT Basic UDI-DIDate15 Feb 2024RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
Optilite® Freelite Mx™ Lambda Free Kit
Model / Reference
LK018.M.OPT, NQ018.M.OPT
Primary DI / UDI-DI
05051700020213
Basic UDI-DI
5051700LK018.M.OPTKT
EMDN Code
W0102010109 Kappa and lambda chain
Device Class
Class C
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 0731dc06-802b-4754-be67-fbf0c8ccd3f3 61 fields · synced 24 Oct 2026