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Phosphorylated Tau 181 Rapid Test Kit (Fluorescence Immunochromatographic Assay)

by Hoyotek Biomedical Co., Ltd. EUDAMED

Active European Union

Ref IF22-01-40Model Please see the IFU.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974738205287 Basic UDI-DIDate16 Sep 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
Fluorescence Immunochromatography Analyzer
Model / Reference
Please see the IFU., IF22-01-40
Primary DI / UDI-DI
06974738205287
Basic UDI-DI
B-06974738205287
EMDN Code
W0102019017 Phosphorylated tau (ptau)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000003570
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hoyotek Biomedical Co., Ltd.

See all devices from Hoyotek Biomedical Co., Ltd. →

Properties

  • Sterile
  • Animal Tissues
  • Reagent

Other properties (7)

  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No