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Automatic Luminescence Immunoassay Analyzer

by Autobio Labtec Instruments Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref 07072Model AutoLumo A1800, AutoLumo A1820, AutoLumo A1860, AutoLumo A1880

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model70UK Basic UDI-DIDate13 Mar 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
AutoLumo A1800, AutoLumo A1820, AutoLumo A1860, AutoLumo A1880, 07072
Primary DI / UDI-DI
06973049096843
Basic UDI-DI
697304909Model70UK
Direct Marketing DI
06973049096843
EMDN Code
W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000012110
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Autobio Labtec Instruments Co., Ltd.

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Properties

Show 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