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FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

by Xiamen Biotime Biotechnology Co., Ltd. China EUDAMED

Ref BT0503005 EMDN W0102160301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06933260205585 Basic UDI-DIDate22 Nov 2022RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
BT0503005
Primary DI / UDI-DI
06933260205585
Basic UDI-DI
B-06933260205585
EMDN Code
W0102160301 Fsh - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000012852
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Xiamen Biotime Biotechnology Co., Ltd.

See all devices from Xiamen Biotime Biotechnology Co., Ltd. →

Properties & raw data

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

Sources (1)

  • EUDAMED a13254f7-fda1-4ce4-af38-802d3f752722 61 fields · synced 25 Oct 2026