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Automatic Coagulation Analyzer

by SysCan MedTech (Suzhou) Co., Ltd China EUDAMED

Ref Ci-300Model Ci-300/Ci-310/Ci-320/Ci-330

EMDN W0202020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697370391Model002GF Basic UDI-DIDate4 Mar 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Ci-300/Ci-310/Ci-320/Ci-330, Ci-300
Primary DI / UDI-DI
06973703911000
Basic UDI-DI
697370391Model002GF
Direct Marketing DI
06973703911000
EMDN Code
W0202020102 Automated coagulometers
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000039109
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from SysCan MedTech (Suzhou) Co., Ltd

See all devices from SysCan MedTech (Suzhou) Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED e4082924-273c-4433-ada6-33f370674aeb 61 fields · synced 23 Oct 2026