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Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref 1 Test/KitRef 5 Tests/KitRef 20 Tests/Kit
Identity
- Device Name
- Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test EUDAMED
- Model / Reference
- 1 Test/Kit EUDAMED5 Tests/Kit EUDAMED20 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166204484 EUDAMED06975166204491 EUDAMED06975166204507 EUDAMED
- Basic UDI-DI
- B-06975166204484 EUDAMEDB-06975166204491 EUDAMEDB-06975166204507 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
Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test by Avioq Bio-tech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975166204484 | Class IVD General | Active |
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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 (4)
- EUDAMED f5c1c4f0-b254-4458-aac9-837d08be0fb7 61 fields · synced Aug 3, 2026
- EUDAMED 18925041-d115-4892-849a-f5746bc8ad4f 61 fields · synced Jul 9, 2026
- EUDAMED 8a69d200-2408-4d5e-8666-99024a24e1fd 61 fields · synced Jul 30, 2026
- EUDAMED 5f75024c-d889-4d4f-98ac-1f981ebad13a 61 fields · synced Aug 3, 2026