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SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)

by Ningbo BESTest Bio-technology Co., Ltd. 2 variants

Ref SI003-01, SI003-05, ISIN-525H, LX-401401Model 1 test/kit, 5 tests/kit, 20 Tests/Kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-000041242SI003-013W Basic UDI-DI Date13 Jan 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Trade Name
SARS-CoV-2 Antigen and Influenza A/B Rapid Test Kit (Immunochromatography)
SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test
Device Name
SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Nasopharyngeal Swab)
Model / Reference
1 test/kit, SI003-01, 5 tests/kit, SI003-05, ISIN-525H, 20 Tests/Kit, LX-401401
Primary DI / UDI-DI
D-000041242SI003-013W, D-000041242SI003-0546, 06936983140171, 06938384622096, 07350123504736, 03664965001044
Basic UDI-DI
B-000041242SI003-013W, B-000041242SI003-0546, B-06936983140171, B-06938384622096, B-07350123504736, B-03664965001044
EMDN Code
W0105070399, W0105070599, W0105090601
Device Class
Class IVD General
Class IVD devices for self-testing
EU market of registration
Germany
Lithuania
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000041242
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Reagent YesEUDAMEDNoEUDAMED
  • Self Testing NoEUDAMEDYesEUDAMED
  • Professional Testing YesEUDAMEDNoEUDAMED

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No