Skip to content

HE4 Rapid Quantitative Test (Chemiluminescence Immunoassay)

by Xiamen Biotime Biotechnology Co., Ltd. EUDAMED

Withdrawn No longer placed on the EU market

Ref BT0506502

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06933260207480 Basic UDI-DIDate24 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  • Withdrawn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European Union — CE/IVDD Withdrawn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

Model / Reference
BT0506502
Primary DI / UDI-DI
06933260207480
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. →