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Adenovirus Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref VIAD-702Model VIADRef VIAD-602
Identity
- Trade Name
- Adenovirus Rapid Test EUDAMED
- Device Name
- Adenovirus Rapid Test EUDAMED
- Model / Reference
- VIAD EUDAMEDVIAD-702 EUDAMEDVIAD-602 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339205421 EUDAMED06937339203212 EUDAMED06937339210210 EUDAMED
- Basic UDI-DI
- B-06937339205421 EUDAMEDB-06937339203212 EUDAMEDB-06937339210210 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Adenovirus Rapid Test by VivaChek Biotech (Hangzhou) 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-06937339205421 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED f625176e-cfbb-4b17-b586-4494c178fd11 61 fields · synced Oct 6, 2026
- EUDAMED 38359e08-5471-4821-89a9-b848cf4fa491 61 fields · synced May 18, 2026
- EUDAMED 09223f8e-8e63-4fe9-bb40-d494b6e72fd7 61 fields · synced Jul 9, 2026