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Automated Coagulation Analyzer

by Shanghai Sun Biotech Co., Ltd. China EUDAMED

Ref UG251EModel UG2510 EMDN W0202020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69382472UG251E-61VC Basic UDI-DIDate13 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
UG2510, UG251E
Primary DI / UDI-DI
06938247225211
Basic UDI-DI
69382472UG251E-61VC
Direct Marketing DI
06938247225211
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 a0002c25-c467-4ce9-b79c-2e1b5a744105 61 fields · synced 23 Oct 2026