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Fully Automated ELISA Workstation

by Yantai Addcare Bio-Tech Co., Ltd. China EUDAMED

Ref NOModel ADC ELISA 1800

EMDN W0201020104

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360915002KA Basic UDI-DIDate6 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Fully Automated ELISA Workstation
Model / Reference
ADC ELISA 1800, NO
Primary DI / UDI-DI
06973609150022
Basic UDI-DI
697360915002KA
Direct Marketing DI
06973609150022
EMDN Code
W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000018409
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Yantai Addcare Bio-Tech 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 2c0b6432-edb8-4f77-b277-ba7944ff5468 61 fields · synced 22 Oct 2026