SARS-CoV-2 Antigen Test (Lateral Flow Assay)
by Wuxi Biohermes Bio & Medical Technology Co., Ltd. China EUDAMED
Ref COV-S61Model 5 Tests/Kit EMDN W0105040699
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-CNMF000014455-COV-S618T | Date13 Jul 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- SARS-CoV-2 Antigen Test (Lateral Flow Assay)
- Model / Reference
- 5 Tests/Kit, COV-S61
- Primary DI / UDI-DI
- D-CNMF000014455-COV-S618T
- Basic UDI-DI
- B-CNMF000014455-COV-S618T
- EMDN Code
- W0105040699 Viral antigen/antibody detection - other
- Device Class
- Class IVD General
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000014455
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd.
See all devices from Wuxi Biohermes Bio & Medical Technology Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED D-CNMF000014455-COV-S618T|B-CNMF000014455-COV-S618T