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D-Dimer Test Kit (Immunofluorescence)

by Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd. China EUDAMED

Ref 2212 EMDN W01021399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978198482127 Basic UDI-DIDate10 Apr 2026RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
2212
Primary DI / UDI-DI
06978198482127
Basic UDI-DI
B-06978198482127
EMDN Code
W01021399 Cardiac markers - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000046524
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.

See all devices from Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 35c61a96-ec87-4c6c-812d-6ed4b11076bf 61 fields · synced 22 Oct 2026