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Automated Coagulation Analyzer

by Shanghai Sun Biotech Co., Ltd. China EUDAMED

Ref U15E, U55E, UR80E, UG24E, U50EModel UP1500, UP5500, UR8000, UG2400, UP5000 EMDN W0202020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69382472U15E-16F9 Basic UDI-DIDate5 Oct 2022RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Device Name
Automated Coagulation Analyzer
Model / Reference
UP1500, U15E, UP5500, U55E, UR8000, UR80E, UG2400, UG24E, UP5000, U50E
Primary DI / UDI-DI
06938247215014, 06938247255010, 06938247200805, 06938247202403, 06938247250060
Basic UDI-DI
69382472U15E-16F9, 69382472U55E-19H3, 69382472U80E-45GL, 69382472UG24E-64QU, 69382472U50E-18FA
Direct Marketing DI
06938247215014
06938247255010
06938247200805
06938247202403
06938247250060
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 (5)

  • EUDAMED f196e8a6-c66f-48d4-bd85-5b4c381f9180 61 fields · synced 22 Oct 2026
  • EUDAMED 06938247255010|69382472U55E-19H3 61 fields · synced 18 May 2026
  • EUDAMED 06938247200805|69382472U80E-45GL 61 fields · synced 18 May 2026
  • EUDAMED 06938247202403|69382472UG24E-64QU 61 fields · synced 18 May 2026
  • EUDAMED 06938247250060|69382472U50E-18FA 61 fields · synced 19 May 2026