Identity
- Trade Name
- Kemilo LH Kit EUDAMED
- Device Name
- Kemilo LH Kit EUDAMED
- Model / Reference
- KM27018 EUDAMEDKM27060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971225939731 EUDAMED06971225939724 EUDAMED
- Basic UDI-DI
- B-06971225939731 EUDAMEDB-06971225939724 EUDAMED
- EMDN Code
- W0102050105 LUTEINISING HORMONE 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 LH 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-06971225939731 | 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 5402c482-857c-403a-a728-5b2790ecb2b2 61 fields · synced Jul 12, 2026
- EUDAMED 02d9d2de-8a4c-4c45-8151-d9e1834547bd 61 fields · synced May 17, 2026