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Respiratory Syncytial Virus Control
EUDAMEDClass IVD General (EU MDR)
Ref VIC122-01-011Model VIC122
Identity
- Trade Name
- Respiratory Syncytial Virus Control EUDAMED
- Device Name
- Respiratory Syncytial Virus Control EUDAMED
- Model / Reference
- VIC122 EUDAMEDVIC122-01-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937339210517 EUDAMED
- Basic UDI-DI
- B-06937339210517 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
The Respiratory Syncytial Virus Control device is a medical device used for the diagnosis and treatment of respiratory syncytial virus (RSV) infections. It is designed to detect the presence of RSV in patient samples, providing accurate and reliable results.
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-06937339210517 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 691e5797-b8ae-4156-abe2-d9b3bad24b94 61 fields · synced Oct 7, 2026