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SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA)
EUDAMEDClass IVD General (EU MDR)
Ref 123015-01-01Ref 123015-20-01
Identity
- Trade Name
- SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA) EUDAMED
- Device Name
- SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA) EUDAMED
- Model / Reference
- 123015-01-01 EUDAMED123015-20-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974167891754 EUDAMED06974167891747 EUDAMED
- Basic UDI-DI
- B-06974167891754 EUDAMEDB-06974167891747 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Poland EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
SARS-CoV-2/FluA/FluB+ADV/RSV/SA Antigen Combo Rapid Test Kit (LFIA) by Jiangsu Medomics Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in…
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974167891754 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Medomics Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030226
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (3)
- EUDAMED 1c2dac5a-aa92-4941-8512-d1fa339ee59d 61 fields · synced Jul 13, 2026
- EUDAMED 775e824d-af9f-456f-befe-6cd73639aca7 61 fields · synced May 17, 2026
- EUDAMED 5f39c5eb-a8d8-463d-bae6-1210d1bd2160 61 fields · synced Jul 13, 2026