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25-hydroxy-vitamin D
EUDAMEDClass IVD General (EU MDR)
Ref 12600787Model 25-hydroxy Vitamin D Quantitative Test Kit (Fluorescence Immunochromatography)
Identity
- Trade Name
- 25-hydroxy-vitamin D EUDAMED
- Device Name
- 25-hydroxy Vitamin D Quantitative Test Kit (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- 25-hydroxy Vitamin D Quantitative Test Kit (Fluorescence Immunochromatography) EUDAMED12600787 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06934175046300PV EUDAMED
- Basic UDI-DI
- B-06934175046300PV EUDAMED
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
25-hydroxy-vitamin D by Changsha Sinocare Inc. — 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-06934175046300PV | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 5f34b49a-b3d4-4091-a9b0-9e3734ddfdb5 61 fields · synced Jul 13, 2026