← Back to catalogue
Renin Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2148E-200Ref S2148E-150
Identity
- Device Name
- Renin Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2148E-200 EUDAMEDS2148E-150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792742734 EUDAMED06955792742727 EUDAMED
- Basic UDI-DI
- B-06955792742734 EUDAMEDB-06955792742727 EUDAMED
- EMDN Code
- W0102060204 RENINE (PLASMA RENINE ACTIVITY) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-06955792742734 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED d928e569-d4d5-4f2c-ad30-1d82d415b7f4 61 fields · synced Jul 24, 2026
- EUDAMED 2ce2f534-b901-4551-92e2-e73ee38b274e 61 fields · synced May 17, 2026