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Thrombelastography Analyzer

by Beijing Lepu Medical Technology Co., Ltd. China EUDAMED

Ref CFMS LEPU-8800

EMDN W0202029001

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number692180760033EN Basic UDI-DIDate29 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
Thrombelastography Analyzer
Model / Reference
CFMS LEPU-8800
Primary DI / UDI-DI
06921807600306
Basic UDI-DI
692180760033EN
Direct Marketing DI
06921807600306
EMDN Code
W0202029001 Thrombelastographs
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000033011
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

Other devices from Beijing Lepu Medical Technology Co., Ltd.

See all devices from Beijing Lepu Medical Technology 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 b233f9ac-ad25-4421-b2a5-e7859b6fe2b6 61 fields · synced 23 Oct 2026