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H-FABP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)

by Nanjing Synthgene Medical Technology Co., Ltd. China EUDAMED

Ref W01021302Model XJ013

EMDN W01021302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974473302531 Basic UDI-DIDate5 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
XJ013, W01021302
Primary DI / UDI-DI
06974473302531
Basic UDI-DI
B-06974473302531
EMDN Code
W01021302 Heart-type fatty acid binding protein
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000023810
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Nanjing Synthgene Medical Technology Co., Ltd.

See all devices from Nanjing Synthgene Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4eb9d486-6868-4692-8aa8-1033c0f14d47 61 fields · synced 22 Oct 2026