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SHBG (eCLIA)

by Shenzhen Lifotronic Technology Co., Ltd. China EUDAMED

Ref 0320509001Model 50T , 50T，2×50T，100T，2×100T

EMDN W0102050109

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975984063690 Basic UDI-DIDate7 May 2025RegisteredStatusActive
European UnionCE/IVDD NumberB-06975984063690 Basic UDI-DIDate7 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
50T, 0320509001, 50T，2×50T，100T，2×100T
Primary DI / UDI-DI
06975984063690
Basic UDI-DI
B-06975984063690, 69703416803205096K2
EMDN Code
W0102050109 Sex hormone binding globulin
Device Class
Class IVD General
Class B
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 & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED e16f4023-7f5e-4455-badc-15bd361d4102 61 fields · synced 22 Oct 2026
  • EUDAMED 06975984063690|69703416803205096K2 61 fields · synced 17 Oct 2026