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Elisa Microplate Reader

by Biobase Biogrand Co., Ltd. China EUDAMED

Ref BK-EL10AModel BK-EL series

EMDN W0201020201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number06978527BK-EL****NP Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
BK-EL series, BK-EL10A
Primary DI / UDI-DI
06978527670003
Basic UDI-DI
06978527BK-EL****NP
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000030480
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Biobase Biogrand Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 450cb1e3-e050-4f9e-8342-4051bd7fea12 61 fields · synced 23 Oct 2026