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Auto Hematology Analyzer

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. EUDAMED 28 variants

Active European Union

Ref VANALYZE-V30sModel Please see UDI-DI for details

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69449040AB3000013ZJ Basic UDI-DIDate22 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
Please see UDI-DI for details, VANALYZE-V30s
Primary DI / UDI-DI
06903053066488
Basic UDI-DI
69449040AB3000013ZJ
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.

See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Properties

  • Surgical Instrument

Other properties (10)

  • 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
  • New Device: No