Identity
- Trade Name
- Kemilo 25-OH-VD Kit EUDAMED
- Device Name
- Kemilo 25-OH-VD Kit EUDAMED
- Model / Reference
- KM38018 EUDAMEDKM38060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971225936167 EUDAMED06971225936150 EUDAMED
- Basic UDI-DI
- B-06971225936167 EUDAMEDB-06971225936150 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Kemilo 25-OH-VD Kit by Goldsite Diagnostics 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-06971225936167 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Goldsite Diagnostics Inc.
- EUDAMED SRN
- CN-MF-000001353
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED d29673cb-eb65-439c-a46e-46ce74a2385e 61 fields · synced Jul 13, 2026
- EUDAMED ae7b16d8-00b9-4fc9-9772-8328c4e3a5fd 61 fields · synced May 18, 2026