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Interleukin-6 Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitRef 100tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kitRef 215390014Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit
Identity
- Device Name
- Interleukin-6 Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMED50tests/kit EUDAMEDReagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED100tests/kit EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215390014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719602407 EUDAMED06972719604623 EUDAMED06972719600854 EUDAMED
- Basic UDI-DI
- B-06972719602407 EUDAMEDB-06972719604623 EUDAMEDB-06972719600854 EUDAMED
- EMDN Code
- W01030609 INTERLEUKIN 6 (IL-6) 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
Interleukin-6 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-06972719602407 | 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 (3)
- EUDAMED 5ea5f873-3678-4f1d-9883-44cc5ea481c9 61 fields · synced Oct 6, 2026
- EUDAMED 6e4b2e43-556a-4ce4-bc30-f199cf879b65 61 fields · synced May 17, 2026
- EUDAMED 42d65307-875f-4802-8057-7c59b85ad1d4 61 fields · synced May 19, 2026