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Rotavirus-Adenovirus-Norovirus Combo Test
EUDAMEDClass B (EU MDR)
Ref A4A130Model Format (cassette): A4A13011 A4A130125 A4A130140 A4A13021 A4A130225 A4A130240Ref MI-F43003
Identity
- Trade Name
- Rotavirus-Adenovirus-Norovirus Combo Test EUDAMED
- Device Name
- Rotavirus-Adenovirus-Norovirus Combo Test EUDAMED
- Model / Reference
- Format (cassette): A4A13011 A4A130125 A4A130140 A4A13021 A4A130225 A4A130240 EUDAMEDA4A130 EUDAMEDMI-F43003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804832476 EUDAMED06952804827083 EUDAMED
- Basic UDI-DI
- 69528048A4A130056 EUDAMEDB-06952804827083 EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMEDW01050499 VIROLOGY REAGENTS - 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
Rotavirus-Adenovirus-Norovirus Combo Test by Assure Tech. (hangzhou) Co., Ltd. — Class B — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69528048A4A130056 | Class B | Active |
| EUDAMED | European Union | CE/IVDD | 69528048A4A130056 | 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 3fd778a3-a13a-4873-9806-39bd74bce90c 61 fields · synced Jul 25, 2026
- EUDAMED d8b7d615-094d-406e-a5e7-b3b2c71a7ed4 61 fields · synced May 11, 2026