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Norovirus GI+GII Rapid Test
EUDAMEDClass B (EU MDR)
Ref A4B271Model Format (cassette): A4B27111 A4B271125 A4B271140 A4B27121 A4B271225 A4B271240
Identity
- Trade Name
- Norovirus GI+GII Rapid Test EUDAMED
- Device Name
- Norovirus GI+GII Rapid Test EUDAMED
- Model / Reference
- Format (cassette): A4B27111 A4B271125 A4B271140 A4B27121 A4B271225 A4B271240 EUDAMEDA4B271 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804811129 EUDAMED
- Basic UDI-DI
- 69528048A4B27106F 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
Norovirus GI+GII 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 | 69528048A4B27106F | 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 85810246-5a31-4675-97bf-9fa7b0c3cfc0 61 fields · synced Jul 23, 2026