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Respiratory Syncytial Virus Antigen Rapid Test
EUDAMEDClass B (EU MDR)
Ref A46210Model A46210120, A46210220Ref /
Identity
- Trade Name
- Respiratory Syncytial Virus Antigen Rapid Test EUDAMEDRespiratory Syncytial Virus Rapid Test EUDAMED
- Device Name
- Respiratory Syncytial Virus Antigen Rapid Test EUDAMEDRespiratory Syncytial Virus Rapid Test EUDAMED
- Model / Reference
- A46210120, A46210220 EUDAMEDA46210 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804811112 EUDAMED06952804809508 EUDAMED
- Basic UDI-DI
- 69528048A462100ZJ EUDAMEDB-06952804809508 EUDAMED
- EMDN Code
- W0105040605 RESPIRATORY SYNCYTIAL VIRUS (RSV) EUDAMEDW0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Spain EUDAMEDNetherlands 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
New Device
No
EUDAMED
Respiratory Syncytial Virus Antigen Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69528048A462100ZJ | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69528048A462100ZJ | Class B | Active |
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Manufacturer
- Manufacturer
- Assure Tech. (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000002170
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED e2201b43-b13f-4950-8d6c-e14cafad4bb0 61 fields · synced Jul 24, 2026
- EUDAMED ddc1b135-a5d8-4ff0-9749-79f58e925842 61 fields · synced Jul 19, 2026