Vascular Endothelial Growth Factor Rapid Test Kit (Fluorescence Immunochromatographic Assay)
by Hoyotek Biomedical Co., Ltd. China EUDAMED
Ref IF17-01-40Model Please see the IFU.
EMDN W0102030199
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974738205188 | Date16 Sep 2023 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- Fluorescence Immunochromatography Analyzer
- Model / Reference
- Please see the IFU., IF17-01-40
- Primary DI / UDI-DI
- 06974738205188
- Basic UDI-DI
- B-06974738205188
- EMDN Code
- W0102030199 Cancer antigens - other
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000003570
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from Hoyotek Biomedical Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 1ae761cb-cb73-4c44-b1dd-f69b2499fc91