Skip to content

Heart Type Fatty Acid Binding Protein Test (Fluorescence Immunoassay)

by Huzhou Jierunxin Biotechnology Co., LTD EUDAMED

Active European Union

Ref 1001031

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06979878281375 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Heart Type Fatty Acid Binding Protein Test (Fluorescence Immunoassay)
Model / Reference
1001031
Primary DI / UDI-DI
06979878281375
Basic UDI-DI
B-06979878281375
EMDN Code
W0102019099 Specific proteins - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000047637
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Huzhou Jierunxin Biotechnology Co., LTD

See all devices from Huzhou Jierunxin Biotechnology 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