Identity
- Trade Name
- VIDAS® NEPHROCHECK® EUDAMED
- Device Name
- VIDAS® NEPHROCHECK® EUDAMED
- Model / Reference
- 421172-03 EUDAMED421172 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03573026617387 EUDAMED03573026554903 EUDAMED
- Basic UDI-DI
- 357302BUDI000859UK EUDAMED
- EMDN Code
- W0102060299 RENAL METABOLISM TESTS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Vidas® Nephrocheck® by Biomerieux Sa — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210793 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 357302BUDI000859UK | Class B | Active |
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Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (3)
- EUDAMED be6b14fe-783a-4ef8-b6f4-6acd5cb5d3e5 61 fields · synced Jul 12, 2026
- EUDAMED 868c2098-ff5a-43d4-9adc-f05158212c5e 61 fields · synced Jul 12, 2026
- FDA 510(k) K210793 1 fields · synced May 18, 2026