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Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref HN215360005Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kitRef 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kitRef 100tests/kitModel Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit
Identity
- Device Name
- Insulin-Like Growth Factor-Ⅰ Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMEDHN215360005 EUDAMEDReagents (include Calibrator 1x1mL/bottle and Control 2x1mL/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 EUDAMED100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719600960 EUDAMED06972719602490 EUDAMED06972719604869 EUDAMED06972719604852 EUDAMED
- Basic UDI-DI
- B-06972719600960 EUDAMEDB-06972719602490 EUDAMEDB-06972719604869 EUDAMEDB-06972719604852 EUDAMED
- EMDN Code
- W0102060403 INSULIN-LIKE GROWTH FACTOR I (SOMATOMEDIN C) 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
Insulin-Like Growth Factor-Ⅰ 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-06972719600960 | 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 b2334e33-cd4a-4efa-8ea7-a32d78e66208 61 fields · synced Oct 6, 2026
- EUDAMED 5146a257-6f7d-4310-8d6a-2aefbcf6de3a 61 fields · synced May 19, 2026
- EUDAMED 7cf0d78d-f49e-4599-88e3-4f15e89fafe5 61 fields · synced May 19, 2026
- EUDAMED 6e3c9bf6-14cb-4a98-91a6-84cbd0adde0f 61 fields · synced May 19, 2026