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Fully Automated ELISA Workstation

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

Withdrawn Not intended for the EU market

Ref （01）6973609150053（11）210108（21）5052021001Model ADC ELISA 600

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360915005KG Basic UDI-DIDate27 Dec 2021RegisteredStatusWithdrawn Not intended for 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  • Withdrawn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European Union — CE/IVDR Withdrawn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

Device Name
Fully Automated ELISA Workstation
Model / Reference
ADC ELISA 600, （01）6973609150053（11）210108（21）5052021001
Primary DI / UDI-DI
06973609150053
Direct Marketing DI
06973609150053
Market of Registration
Austria

Manufacturer details

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

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