Identity
- Trade Name
- Time resolved Fluoroimmunoassay Analyzer EUDAMED
- Device Name
- Time resolved Fluoroimmunoassay Analyzer EUDAMED
- Model / Reference
- FIA Go EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977125152492 EUDAMED
- Basic UDI-DI
- 697122593GS48014AL7 EUDAMED
- EMDN Code
- W02010299 IMMUNOCHEMISTRY INSTRUMENTS - OTHER 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
Yes
EUDAMED
New Device
No
EUDAMED
Time resolved Fluoroimmunoassay Analyzer 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 | 697122593GS48014AL7 | 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 5326c523-dc37-417c-a07f-1c715f4c59ec 61 fields · synced Jun 18, 2026