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Automatic Luminescence Immunoassay Analyzer

by Autobio Labtec Instruments Co., Ltd. China EUDAMED

Ref 07064Model AutoLumo A6000、AutoLumo A6200、AutoLumo A6600、AutoLumo A6800 EMDN W0201020103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model72UP Basic UDI-DIDate14 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  • Withdrawn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European Union — CE/IVDR Withdrawn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 · synced 23 Oct 2026

Model / Reference
AutoLumo A6000、AutoLumo A6200、AutoLumo A6600、AutoLumo A6800, 07064
Primary DI / UDI-DI
06973049096911
Basic UDI-DI
697304909Model72UP
Direct Marketing DI
06973049096911
EMDN Code
W0201020103 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput > 250 and <= 700 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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 2e9671e2-a9e2-4635-8254-8c0d3bf48e42 61 fields · synced 23 Oct 2026