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SARS-CoV-2/Flu A&B Antigen Combo Rapid Test

EUDAMED

Class IVD General (EU MDR)

Ref 1 Test/KitRef C011932Ref 20 Tests/Kit

by Avioq Bio-tech Co., Ltd.

Identity

Device Name
SARS-CoV-2/Flu A&B Antigen Combo Rapid Test EUDAMED
SARS-CoV-2 & Flu A+B Antigen Combo Rapid Test Kit EUDAMED
Model / Reference
1 Test/Kit EUDAMED
C011932 EUDAMED
20 Tests/Kit EUDAMED

Identifiers

Primary DI / UDI-DI
06975166204309 EUDAMED
06950917930348 EUDAMED
06975166204323 EUDAMED
Basic UDI-DI
B-06975166204309 EUDAMED
B-06950917930348 EUDAMED
B-06975166204323 EUDAMED
EMDN Code
W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMED
W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
W0105090601 CORONAVIRUS / INFLUENZA - RT & POC EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria EUDAMED
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

SARS-CoV-2/Flu A&B Antigen Combo Rapid Test by Avioq Bio-tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Avioq Bio-tech Co., Ltd.
EUDAMED SRN
CN-MF-000048146
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (3)

  • EUDAMED e4c355ef-6e18-46c2-9414-c9f90b6aad54 61 fields · synced Jul 13, 2026
  • EUDAMED bd41ba7c-3ac6-4d45-8bda-2708796ba406 61 fields · synced May 18, 2026
  • EUDAMED ef1d9b75-3d96-489c-a2fd-73adbab52698 61 fields · synced Jul 13, 2026