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Coagulation Analyzer

by Shanghai Sun Biotech Co., Ltd. China EUDAMED

Ref UG5EModel UG500

EMDN W0202020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69382472UG5E-49Q9 Basic UDI-DIDate5 Sep 2024RegisteredStatusActive

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
Coagulation Analyzer
Model / Reference
UG500, UG5E
Primary DI / UDI-DI
06938247200515
Basic UDI-DI
69382472UG5E-49Q9
Direct Marketing DI
06938247200515
EMDN Code
W0202020101 Semi-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

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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 a79acb8e-cc89-4951-8b58-dc05baff93c6 61 fields · synced 22 Oct 2026