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Free Estriol（FE3）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）

by Biobase Diagnostic Technology (Shandong) Co., Ltd. EUDAMED

Active European Union

Ref 200 Tests/kit（DR1122-3）Model 200 Tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974969982629 Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
200 Tests/kit, 200 Tests/kit（DR1122-3）
Primary DI / UDI-DI
06974969982629
Basic UDI-DI
B-06974969982629
EMDN Code
W0102050203 Unconjugated (free) estriol
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025964
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No