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InfectCheck SARS-CoV-2/RSV/FluA/FluB
EUDAMEDClass IVD General (EU MDR)
Ref 811028/ K12-RVPanel4
Identity
- Trade Name
- InfectCheck SARS-CoV-2/RSV/FluA/FluB EUDAMED
- Device Name
- SARS-CoV-2/RSV/ FluA/ FluB Antigen Rapid Test EUDAMED
- Model / Reference
- 811028/ K12-RVPanel4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-K12-RVPanel4CU EUDAMED
- Basic UDI-DI
- B-K12-RVPanel4CU EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
InfectCheck SARS-CoV-2/RSV/FluA/FluB by Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-K12-RVPanel4CU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024153
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b394c6f1-e42c-48ac-be6f-7d63011d1a4f 61 fields · synced Oct 7, 2026