Carcinoembryonic antigen (CEA) Quantitative Test Kit (Dry Fluorescence Immunochromatographic Assay, FIA)
by Jiangsu Confidence Medical Technology Co., Ltd China EUDAMED
Ref 1 test/kit EMDN W0102030112
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06979355923118 | Date16 Dec 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Carcinoembryonic antigen (CEA) Quantitative Test Kit (Dry Fluorescence Immunochromatographic Assay, FIA)
- Model / Reference
- 1 test/kit
- Primary DI / UDI-DI
- 06979355923118
- Basic UDI-DI
- B-06979355923118
- EMDN Code
- W0102030112 Carcinoembryonic antigen
- 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
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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 58436c4a-a91e-457d-b8c9-7c1d6aa4afc3