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25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit
EUDAMEDClass IVD General (EU MDR)
Ref 50tests/kitModel Reagents（include Calibrator 2x1mL/bottle and Control 2x1mL/bottle )50tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )50tests/kitRef 215260017Model Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kitRef 100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kitModel Reagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit
Identity
- Device Name
- 25-Hydroxy Vitamin D Chemiluminescence Immunoassay Kit EUDAMED
- Model / Reference
- Reagents（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 1x1mL/bottle and Control 1x1mL/bottle): 100tests/kit EUDAMED215260017 EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )50tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 2x1mL/bottle )100tests/kit EUDAMED100tests/kit EUDAMEDReagents（include Calibrator 1x1mL/bottle and Control 1x1mL/bottle )100tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972719604159 EUDAMED06972719601950 EUDAMED06972719600571 EUDAMED06972719601967 EUDAMED06972719601943 EUDAMED06972719606375 EUDAMED
- Basic UDI-DI
- B-06972719604159 EUDAMEDB-06972719601950 EUDAMEDB-06972719600571 EUDAMEDB-06972719601967 EUDAMEDB-06972719601943 EUDAMEDB-06972719606375 EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D 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
25-Hydroxy Vitamin D 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-06972719604159 | 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 (6)
- EUDAMED 629afc32-7635-4a2d-bfc5-51891944db40 61 fields · synced Oct 7, 2026
- EUDAMED 2c34c8b4-8720-4c45-bf1c-6e3f56ce6ca2 61 fields · synced May 17, 2026
- EUDAMED 25f99c1c-89ae-4b5c-8e15-d74e1433fb24 61 fields · synced May 17, 2026
- EUDAMED 49e1ea5e-8d34-4ef2-b70f-2040c3c9de11 61 fields · synced May 18, 2026
- EUDAMED 15e69962-ee14-4d1e-a807-201c9a9c0b7d 61 fields · synced May 19, 2026
- EUDAMED 86160c05-c9b7-4ba3-99f7-20cba18b6fb0 61 fields · synced Jul 11, 2026