Used for the in vitro quantitative determination of angiotensin I in human plasma. Clinically used for the auxiliary evaluation of cardiovascular function.
by Jiangsu Confidence Medical Technology Co., Ltd
Ref 25 tests/kit (including calibration and control)
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06979355926980 06979355926980 | Date19 Dec 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Device Name
- Used for the in vitro quantitative determination of angiotensin I in human plasma. Clinically used for the auxiliary evaluation of cardiovascular function.
- Model / Reference
- 25 tests/kit (including calibration and control)
- Primary DI / UDI-DI
- 06979355926980
- Basic UDI-DI
- B-06979355926980
- EMDN Code
- W0102060202 Angiotensin i / II
- Device Class
- Class IVD General
- EU 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
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