Renin (eCLIA)
by Shenzhen Lifotronic Technology Co., Ltd. 4 variants
Ref 0320511902Model 2×50T, 50T,2×50T,100T,2×100T
Active
CE IVDR CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | NumberB-06975984067179 06975984067179 | Date24 Apr 2026 | StatusActive |
| European Union | CE/IVDD | NumberB-06975984067179 06975984067179 | Date24 Apr 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR, CE/IVDD Active
Specification
- Model / Reference
- 2×50T, 0320511902, 50T,2×50T,100T,2×100T
- Primary DI / UDI-DI
- 06975984067179
- Basic UDI-DI
- B-06975984067179, 69703416803205109JJ
- EMDN Code
- W0102060204 Renine (plasma renine activity)
- Device Class
- Class IVD GeneralClass B
- EU market of registration
- NetherlandsGermany
Manufacturer details
- EUDAMED SRN
- CN-MF-000005654
- Authorised representative
- Umedwings Netherlands B.V. NL-AR-000000444
Other devices from Shenzhen Lifotronic Technology Co., Ltd.
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Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No