← Back to catalogue
C-Reactive Protein Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 100tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kitRef 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit
Identity
- Device Name
- C-Reactive Protein Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kit EUDAMED100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit EUDAMED50tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit EUDAMEDReagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719605804 EUDAMED06972719605781 EUDAMED06972719605798 EUDAMED06972719605811 EUDAMED06972719606276 EUDAMED06972719606283 EUDAMED
- Basic UDI-DI
- B-06972719605804 EUDAMEDB-06972719605781 EUDAMEDB-06972719605798 EUDAMEDB-06972719605811 EUDAMEDB-06972719606276 EUDAMEDB-06972719606283 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN 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-Reactive Protein Chemiluminescence Immunoassay Kit by Nanjing RealMind Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06972719605804 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000024838
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 0ab64d58-e53d-444d-9408-407bb654fdfc 61 fields · synced Oct 7, 2026
- EUDAMED 705606f2-b6b1-4759-8bbf-fa7f996b53f4 61 fields · synced May 17, 2026
- EUDAMED 6130b289-443f-4bf1-9e7c-c64db4eda289 61 fields · synced May 19, 2026
- EUDAMED ca0e0938-3cda-4886-b140-1bf9b25f2525 61 fields · synced May 19, 2026
- EUDAMED 086e32d0-b1e6-4866-8c80-d1e8a4f1fb81 61 fields · synced Jul 11, 2026
- EUDAMED 96888e3e-90c5-4542-a62d-f915ab27fbe8 61 fields · synced Jul 31, 2026