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ELISA Reader

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

Ref （01）6973609150190（11）210518（21）5C12021002Model DM 801B

EMDN W0201020201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360915019KT Basic UDI-DIDate16 Jun 2022RegisteredStatusActive

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
ELISA Reader
Model / Reference
DM 801B, （01）6973609150190（11）210518（21）5C12021002
Primary DI / UDI-DI
06973609150190
Basic UDI-DI
697360915019KT
Direct Marketing DI
06973609150190
EMDN Code
W0201020201 Immunochemistry readers
Device Class
Class A
Market of Registration
Romania

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.

See all devices from Yantai Addcare Bio-Tech 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 9b88777a-be4c-4c4f-bbe0-37a0f7146baf 61 fields · synced 22 Oct 2026