Homocysteine(Hcy) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)
by Jiangsu Confidence Medical Technology Co., Ltd EUDAMED
Active
Ref 40 tests/kit
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06979355921749 | Date15 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Homocysteine(Hcy) Quantitative Test Kit(Dry Fluorescence Immunochromatographic Assay, FIA)
- Model / Reference
- 40 tests/kit
- Primary DI / UDI-DI
- 06979355921749
- Basic UDI-DI
- B-06979355921749
- EMDN Code
- W01021307 Homocysteine
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000050949
- Authorised representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Other devices from Jiangsu Confidence Medical Technology Co., Ltd
See all devices from Jiangsu Confidence Medical Technology Co., Ltd →
Properties
Show properties
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