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Clean II

by Shanghai Sun Biotech Co., Ltd. China EUDAMED

Ref 8063E

EMDN W0202020185

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69382472CleanII-22T9 Basic UDI-DIDate28 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Clean II
Model / Reference
8063E
Primary DI / UDI-DI
06938247281330
Basic UDI-DI
69382472CleanII-22T9
EMDN Code
W0202020185 Coagulometers - consumables
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000027682
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Sun Biotech Co., Ltd.

See all devices from Shanghai Sun Biotech 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 (1)

  • EUDAMED 22e557fd-162d-4b58-8cd3-e7b2484041e3 61 fields · synced 22 Oct 2026