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Rotavirus and Adenovirus Combo Rapid Test
EUDAMEDClass B (EU MDR)
Ref A4A230Model Format (cassette): A4A23011 A4A230125 A4A230140 A4A23021 A4A230225 A4A230240
Identity
- Trade Name
- Rotavirus and Adenovirus Combo Rapid Test EUDAMED
- Device Name
- Rotavirus and Adenovirus Combo Rapid Test EUDAMED
- Model / Reference
- Format (cassette): A4A23011 A4A230125 A4A230140 A4A23021 A4A230225 A4A230240 EUDAMEDA4A230 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832469 EUDAMED
- Basic UDI-DI
- 69528048A4A23005D EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain 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
Rotavirus and Adenovirus Combo Rapid Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69528048A4A23005D | 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 (1)
- EUDAMED f3a99bb5-edbc-49e6-bb4a-c885964a9426 61 fields · synced Jul 24, 2026