Identity
- Trade Name
- G-3LHB Lyse EUDAMED
- Device Name
- G-3LHB Lyse EUDAMED
- Model / Reference
- G-3LHB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977125152263 EUDAMED
- Basic UDI-DI
- 697122593GS61165D6 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
G-3LHB Lyse by Goldsite Diagnostics Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697122593GS61165D6 | Class A | 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 (1)
- EUDAMED de7ff936-689d-41a6-8b2e-46aab6b7bab4 61 fields · synced Jun 19, 2026