Human CYP2C19 Gene Detection Kit(PCR-Fluorescence Method)
by Wuhan YZY Medical Science and Technology Co., Ltd China EUDAMED
Ref YZYMT-006-CE EMDN W0106030104
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06974604720036 | Date23 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Human CYP2C19 Gene Detection Kit(PCR-Fluorescence Method)
- Model / Reference
- YZYMT-006-CE
- Primary DI / UDI-DI
- 06974604720036
- Basic UDI-DI
- B-06974604720036
- EMDN Code
- W0106030104 Cyp2c19
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000036323
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Professional Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 9600a00e-5ae7-4369-bf90-2ebe7f3e8fcb