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C-Reactive Protein Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2136E-75Ref S2136E-150Ref S2136E-25
Identity
- Device Name
- C-Reactive Protein Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2136E-75 EUDAMEDS2136E-150 EUDAMEDS2136E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792741980 EUDAMED06955792742000 EUDAMED06955792741966 EUDAMED
- Basic UDI-DI
- B-06955792741980 EUDAMEDB-06955792742000 EUDAMEDB-06955792741966 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN 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
C-Reactive Protein 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-06955792741980 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Sansure Biotech Inc.
- EUDAMED SRN
- CN-MF-000011392
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 16fb917b-37db-4ee8-bdb8-10da8368dab7 61 fields · synced Aug 1, 2026
- EUDAMED 04c98fa0-f690-4137-9890-527620ca50c2 61 fields · synced May 18, 2026
- EUDAMED c9ebb9d3-dfe9-4039-881c-b1eed5da8ce7 61 fields · synced May 19, 2026