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Cleaning Solution for Hematology Analyzer

by Zhongshan Chuangyi Biochemical Engineering Co., Ltd. EUDAMED

Active European Union

Ref ManyModel Compatible SYSMEX, MINDRAY, COULTER, ABBOTT, NIHON KOHDEN, ERMA, MEDONIC, RAYTO, PROCAN, URIT, DIRUI, SWELAB-AC, CIS, DANAM, ABX, ABACUS hematology analyzer.

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697873495IVDR-A3X Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
Compatible SYSMEX, MINDRAY, COULTER, ABBOTT, NIHON KOHDEN, ERMA, MEDONIC, RAYTO, PROCAN, URIT, DIRUI, SWELAB-AC, CIS, DANAM, ABX, ABACUS hematology analyzer., Many
Primary DI / UDI-DI
06978734955955
Basic UDI-DI
697873495IVDR-A3X
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000033816
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Surgical Instrument: No
  • New Device: No