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Automatic Hematology Analyzer

by Shenzhen CoooSeee Biomedical Co., Ltd. EUDAMED

Withdrawn Not intended for the EU market

Ref 1360E-PA00002Model CH8300CRP CH8301CRP CH8302CRP CH8300 CH8301 CH8302 CH8310 CH8311 CH8312

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697806677CH005J3 Basic UDI-DIDate22 Aug 2026RegisteredStatusWithdrawn 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  • Withdrawn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European Union — CE/IVDR Withdrawn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

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
CH8300CRP CH8301CRP CH8302CRP CH8300 CH8301 CH8302 CH8310 CH8311 CH8312, 1360E-PA00002
Primary DI / UDI-DI
06978066778277
Basic UDI-DI
697806677CH005J3
EMDN Code
W0202010201 Automated 3 part hematology analysers
Device Class
Class B

Manufacturer details

EUDAMED SRN
CN-MF-000045646
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen CoooSeee Biomedical Co., Ltd.

See all devices from Shenzhen CoooSeee Biomedical Co., Ltd. →

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