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Automated Coagulation Analyzer

by Shanghai Sun Biotech Co., Ltd. China EUDAMED

Ref UG12EModel UG1200

EMDN W0202020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69382472UG12E-101V6 Basic UDI-DIDate20 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Automated Coagulation Analyzer
Model / Reference
UG1200, UG12E
Primary DI / UDI-DI
06938247212006
Basic UDI-DI
69382472UG12E-101V6
Direct Marketing DI
06938247212006
EMDN Code
W0202020102 Automated coagulometers
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
  • 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 9c8caade-b13f-4420-be85-3d1d3d23726d 61 fields · synced 23 Oct 2026