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Tigsun Flu A/B, RSV, COVID-19 Ag Combo Test

by Beijing Tigsun Diagnostics Co., Ltd. EUDAMED

Active European Union

Model 20 tests

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973642382503 Basic UDI-DIDate16 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  • Withdrawn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 Flu A/B, RSV, COVID-19 Ag Combo Test
Model / Reference
20 tests
Primary DI / UDI-DI
06973642382503
Basic UDI-DI
B-06973642382503
EMDN Code
W0105070399 Multiple viruses - multiplex assays - other
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