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CLIA-go Pro Chemiluminescence Immunoassay Analyzer

by Healgen Life Science, LLC EUDAMED

Active European Union

Ref GR-036Model Lumini-C100

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0850076346Lumini-CET Basic UDI-DIDate6 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Lumini-C100, GR-036
Primary DI / UDI-DI
30850076346103
Basic UDI-DI
0850076346Lumini-CET
EMDN Code
W0201020299 Limited panel immunochemistry analysers - other
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
US-MF-000043017
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No