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Fully Automated Blood Grouping System

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

Withdrawn Not intended for the EU market

Ref （01）6973609150770（11）210112（21）5772021001, （01）6973609150763（11）210113（21）5762021001, （01）6973609150756（11）210110（21）5752021001Model Blozer 200, Blozer 120, Blozer 72

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697360915077L9 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  • Withdrawn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European Union — CE/IVDR Withdrawn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 Blood Grouping System
Model / Reference
Blozer 200, （01）6973609150770（11）210112（21）5772021001, Blozer 120, （01）6973609150763（11）210113（21）5762021001, Blozer 72, （01）6973609150756（11）210110（21）5752021001
Primary DI / UDI-DI
06973609150770, 06973609150763, 06973609150756
Basic UDI-DI
697360915077L9, 697360915076L7, 697360915075L5
Direct Marketing DI
06973609150770
06973609150763
06973609150756
EMDN Code
W0202030102 Automated blood grouping analysers
Device Class
Class A
Market of Registration
Austria

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

Show properties
  • 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