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D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)

by Jiangsu Confidence Medical Technology Co., Ltd China EUDAMED

Ref 10 tests/kit EMDN W0103020503

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06979355921022 Basic UDI-DIDate15 Dec 2025RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Device Name
D-Dimer Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)
Model / Reference
10 tests/kit
Primary DI / UDI-DI
06979355921022
Basic UDI-DI
B-06979355921022
EMDN Code
W0103020503 D-dimer
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000050949
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

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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 2ddcc2c8-bdc0-4e22-8322-49a83b913ee5 61 fields · synced 24 Oct 2026