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Influenza A/B Rapid Test Device
EUDAMEDClass B (EU MDR)
Ref A46071Model A46071120,A46071220
Identity
- Trade Name
- Influenza A/B Rapid Test Device EUDAMED
- Device Name
- Influenza A/B Rapid Test Device EUDAMED
- Model / Reference
- A46071120,A46071220 EUDAMEDA46071 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952804809478 EUDAMED
- Basic UDI-DI
- 69528048A46071028 EUDAMED
- EMDN Code
- W0105099004 INFLUENZA A AND /OR B - RT & POC 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
Influenza A/B Rapid Test Device 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 | 69528048A46071028 | 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 b01b826f-a34d-4827-bd45-84d62b2adbac 61 fields · synced Jun 19, 2026