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C-Peptide Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref S2012E-150Ref S2012E-200Ref S2012E-100Ref S2012E-75Ref S2012E-25
Identity
- Device Name
- C-Peptide Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- S2012E-150 EUDAMEDS2012E-200 EUDAMEDS2012E-100 EUDAMEDS2012E-75 EUDAMEDS2012E-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955792736986 EUDAMED06955792736993 EUDAMED06955792736979 EUDAMED06955792736962 EUDAMED06955792736948 EUDAMED
- Basic UDI-DI
- B-06955792736986 EUDAMEDB-06955792736993 EUDAMEDB-06955792736979 EUDAMEDB-06955792736962 EUDAMEDB-06955792736948 EUDAMED
- EMDN Code
- W0102060101 C-PEPTIDE 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-Peptide 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-06955792736986 | 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 (5)
- EUDAMED d49da0c5-ad1e-4bcf-b833-cb6e927553c3 61 fields · synced Jul 23, 2026
- EUDAMED e3e47117-1a13-45ad-ab89-d3d84ace5443 61 fields · synced May 17, 2026
- EUDAMED 029bdaee-755b-47aa-a029-f13e9173f4d5 61 fields · synced May 17, 2026
- EUDAMED 9df1f744-ad6c-41b6-a6a2-bf826cfd5969 61 fields · synced May 18, 2026
- EUDAMED fd9e2460-6046-4c6a-b3b5-e482bd75d8d0 61 fields · synced May 18, 2026