Skip to content

Heart-Type Fatty Acid-Binding Protein Rapid Test Kit (Fluorescence Immunochromatographic Assay)

by Hoyotek Biomedical Co., Ltd. EUDAMED

Active European Union

Ref IF16-01-40Model Please see the IFU.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974738205164 Basic UDI-DIDate15 Sep 2023RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Fluorescence Immunochromatography Analyzer
Model / Reference
Please see the IFU., IF16-01-40
Primary DI / UDI-DI
06974738205164
Basic UDI-DI
B-06974738205164
EMDN Code
W01021302 Heart-type fatty acid binding protein
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

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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