← Back to catalogue
SARS-CoV-2/Flu A&B/RSV/AdV Antigen Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 1 Test/Kit
Identity
- Device Name
- SARS-CoV-2/Flu A&B/RSV/AdV Antigen Combo Rapid Test EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166204347 EUDAMED
- Basic UDI-DI
- B-06975166204347 EUDAMED
- EMDN Code
- W0101060199 BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER EUDAMEDW0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
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/RSV/AdV 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975166204347 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Avioq Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048146
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 0d7adedc-f71e-4caa-a4af-22ab6e44428a 61 fields · synced Sep 18, 2026
- EUDAMED ea32c8f9-9f0c-46be-9b12-048769a07a7f 61 fields · synced Sep 18, 2026