Skip to content

Automatic Luminescence Immunoassay Analyzer

by Autobio Labtec Instruments Co., Ltd. China EUDAMED

Ref 07021Model AutoLumo A2000Plus EMDN W0201020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697304909Model69V2 Basic UDI-DIDate17 Jul 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  • Withdrawn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 22 Oct 2026

Model / Reference
AutoLumo A2000Plus, 07021
Primary DI / UDI-DI
06973049096829
Basic UDI-DI
697304909Model69V2
Direct Marketing DI
06973049096829
EMDN Code
W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
Device Class
Class A
Market of Registration
Italy

Manufacturer details

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

Other devices from Autobio Labtec Instruments Co., Ltd.

See all devices from Autobio Labtec Instruments Co., Ltd. →

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 b24ff386-490c-4aef-868b-5afdfe952078 61 fields · synced 22 Oct 2026