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Tigsun sFIt-1 Antigen Rapid Test (FIA)

by Beijing Tigsun Diagnostics Co., Ltd. EUDAMED

Active European Union

Model 50 tests

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973642381452 Basic UDI-DIDate14 May 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  • Withdrawn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

Device Name
Tigsun sFIt-1 Antigen Rapid Test (FIA)
Model / Reference
50 tests
Primary DI / UDI-DI
06973642381452
Basic UDI-DI
B-06973642381452
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.

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Properties

Show properties
  • 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