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Renin (eCLIA)
EUDAMEDClass IVD General (EU MDR)
Ref 0320511901Model 50TRef 0320511904Model 2×100TRef 0320511902Model 2×50T
Identity
- Trade Name
- Renin (eCLIA) EUDAMED
- Device Name
- Renin (eCLIA) EUDAMED
- Model / Reference
- 50T EUDAMED0320511901 EUDAMED2×100T EUDAMED0320511904 EUDAMED2×50T EUDAMED0320511902 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984067155 EUDAMED06975984067162 EUDAMED06975984067179 EUDAMED
- Basic UDI-DI
- B-06975984067155 EUDAMEDB-06975984067162 EUDAMEDB-06975984067179 EUDAMED
- EMDN Code
- W0102060204 RENINE (PLASMA RENINE ACTIVITY) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Renin (eCLIA) by Shenzhen Lifotronic Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975984067155 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED f50cf77d-312f-4848-97cb-d6efef23e77d 61 fields · synced Sep 18, 2026
- EUDAMED 5f153fb5-c65f-4a23-8908-2aeff8fd691b 61 fields · synced May 17, 2026
- EUDAMED d6e69a29-1a1e-41fe-b56e-c0ca22a779c9 61 fields · synced May 18, 2026