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Respiratory Syncytial Virus (RSV) Antigen Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref RSV-B02b
Identity
- Trade Name
- Respiratory Syncytial Virus (RSV) Antigen Rapid Test EUDAMED
- Device Name
- Respiratory Syncytial Virus (RSV) Antigen Rapid Test EUDAMED
- Model / Reference
- RSV-B02b EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-RSV-B02bTT EUDAMED
- Basic UDI-DI
- B-RSV-B02bTT EUDAMED
- EMDN Code
- W0105099002 RSV - RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Respiratory Syncytial Virus (RSV) Antigen Rapid Test by Hangzhou Aichek Medical Technology 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-RSV-B02bTT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 289541bf-9282-465b-9d66-82a619483439 61 fields · synced Jul 21, 2026