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Auto Coagulation Analyzer

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED

Active European Union

Ref BC-5000Model BC-5000、BC-5120、BC-5130、BC-5140、BC-5150、Unicorn 5、Counter 29、Mispa CountZ

Overview

The Auto Coagulation Analyzer is a high-precision medical device used for accurate hematology testing in healthcare settings. Developed by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., this instrument provides reliable results and improves patient outcomes.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB3000010ZC Basic UDI-DIDate24 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Auto Hematology Analyzer
Model / Reference
BC-5000、BC-5120、BC-5130、BC-5140、BC-5150、Unicorn 5、Counter 29、Mispa CountZ, BC-5000
Primary DI / UDI-DI
06944904051055
Basic UDI-DI
69449040AB3000010ZC
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics 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