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IMMULITE 2000 Unconjugated Estriol

by Siemens Healthcare Diagnostics Products Ltd. FDA registration: Germany EUDAMED

Ref 10381171Model IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol EMDN W0102050203

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number0405686901473VR Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol
Model / Reference
IVDR_67_LLB_DUB-C_C_REAG_KIT_Unconjugated Estriol, 10381171
Primary DI / UDI-DI
00630414971698
Basic UDI-DI
0405686901473VR
EMDN Code
W0102050203 Unconjugated (free) estriol
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000016339
Authorised representative
Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763

Other devices from Siemens Healthcare Diagnostics Products Limited

See all devices from Siemens Healthcare Diagnostics Products Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 71298e3d-b097-49c3-ab84-332f7e290fac 61 fields · synced 24 Oct 2026