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Zika Antigen Assay Kit(Colloidal gold)
EUDAMEDClass IVD General (EU MDR)
Ref 20 Tests/Kit
Identity
- Device Name
- Zika Antigen Assay Kit(Colloidal gold) EUDAMED
- Model / Reference
- 20 Tests/Kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975166201438 EUDAMED
- Basic UDI-DI
- B-06975166201438 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER 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
Zika Antigen Assay Kit(Colloidal gold) 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-06975166201438 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Avioq Bio-tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000048146
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5722bb32-7f56-4b92-9610-c63d37c0f812 61 fields · synced Jul 11, 2026