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D-Dimer STAT (eCLIA)

by Shenzhen Lifotronic Technology Co., Ltd. 4 variants

Ref 0320500304Model 2×100T, 50T，2×50T，100T，2×100T

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975984063034 Basic UDI-DI 06975984063034UDI-DIDate24 Apr 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06975984063034 Basic UDI-DI 06975984063034UDI-DIDate24 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Model / Reference
2×100T, 0320500304, 50T，2×50T，100T，2×100T
Primary DI / UDI-DI
06975984063034
Basic UDI-DI
B-06975984063034, 69703416803205040J7
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Class C
EU market of registration
Netherlands
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000005654
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Shenzhen Lifotronic Technology Co., Ltd.

See all devices from Shenzhen Lifotronic Technology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No