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C-Peptide Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 215170011Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kitRef 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kitRef 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit
Identity
- Device Name
- C-Peptide Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215170011 EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719601127 EUDAMED06972719605163 EUDAMED06972719601554 EUDAMED06972719605156 EUDAMED
- Basic UDI-DI
- B-06972719601127 EUDAMEDB-06972719605163 EUDAMEDB-06972719601554 EUDAMEDB-06972719605156 EUDAMED
- EMDN Code
- W0102060101 C-PEPTIDE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
C-Peptide Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech 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-06972719601127 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED 13360d97-08c1-46be-b7c3-47358c1761e0 61 fields · synced Oct 6, 2026
- EUDAMED 198c35c7-e0ad-48b8-96ef-3f85b0c748ab 61 fields · synced May 11, 2026
- EUDAMED 4c76f293-9e94-40aa-b9d0-9ef508dc8ee3 61 fields · synced May 17, 2026
- EUDAMED 13805cb0-ea90-4073-b7a2-06cc8a4bc4d8 61 fields · synced May 19, 2026