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Automatic Chemiluminescence Immunoassay Analyzer

by Rapid Labs Ltd EUDAMED

Active European Union

Ref RL-CLIA-1AModel Analyzer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5060599400002VP7 Basic UDI-DIDate27 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  • Withdrawn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
Analyzer, RL-CLIA-1A
Primary DI / UDI-DI
5060599402017
Direct Marketing DI
5060599402017
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
GB-MF-000026335
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Rapid Labs Ltd

See all devices from Rapid Labs Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 5e21eaf9-a171-4140-bf06-3edd0b4fce8e 61 fields · synced 24 Oct 2026