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5in1VIRENTEST , SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
EUDAMEDClass D (EU MDR)
Ref 123143-01-102Model 123143-01-102 123143-02-102 123143-05-102 123143-20-102
Identity
- Trade Name
- 5in1VIRENTEST , SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA) EUDAMED
- Device Name
- SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA) EUDAMED
- Model / Reference
- 123143-01-102 123143-02-102 123143-05-102 123143-20-102 EUDAMED123143-01-102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974167891655 EUDAMED
- Basic UDI-DI
- 697416789100NQ EUDAMED
- Direct Marketing DI
- 06974167891655 EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER EUDAMED
Classification
- Device Class
- Class D EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
5in1VIRENTEST , SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA) by Jiangsu Medomics Medical Technology Co., Ltd. — Class D — IVDR — listed in…
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 | 697416789100NQ | Class D | Active |
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Manufacturer
- Manufacturer
- Jiangsu Medomics Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000030226
- Authorised Representative
- Mega Eurostar Sp. z o.o. PL-AR-000042730
Sources (1)
- EUDAMED 56638174-4aee-43a7-b40b-461587554d68 61 fields · synced Oct 6, 2026