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Rinse Solution

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

Ref Ci-W-3500Model Ci-W-2000

EMDN W0104010899

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697449025R002HP Basic UDI-DIDate17 Jun 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Ci-W-2000, Ci-W-3500
Primary DI / UDI-DI
06974490250136, 06974490250129
Basic UDI-DI
697449025R002HP, 697449025R001HM
Direct Marketing DI
06974490250136
06974490250129
EMDN Code
W0104010899 Buffers, stains - other
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000040462
Authorised representative
Obelis s.a. BE-AR-000000106

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

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

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED 4384d34f-cb48-44a7-b2d0-b4189b933211 61 fields · synced 25 Oct 2026
  • EUDAMED 06974490250129|697449025R001HM 61 fields · synced 18 May 2026