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Tigsun sFIt-1 Antigen Rapid Test (FIA)

by Beijing Tigsun Diagnostics Co., Ltd. China EUDAMED

Ref N/AModel 40 tests

EMDN W0102050212

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06973642381445 Basic UDI-DIDate14 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Tigsun sFIt-1 Antigen Rapid Test (FIA)
Model / Reference
40 tests, N/A
Primary DI / UDI-DI
06973642381445
Basic UDI-DI
B-06973642381445
EMDN Code
W0102050212 Soluble fms-like tyrosine kinase-1
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034480
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Beijing Tigsun Diagnostics Co., Ltd.

See all devices from Beijing Tigsun Diagnostics 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 4276e594-a4b7-4370-bb90-bafdc51a0d52 61 fields · synced 22 Oct 2026