EUDAMED last updated this device on Aug 26, 2026
FilmArray® 2.0 Instrument
357302BUDI000020SGOn the marketIVDR Class A
- Applicable legislation
- —
- Organization name
- BioFire Diagnostics, LLC
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →- 00815381020031
- Reference / catalog number
- FLM2-ASY-0001
Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.
FilmArray® 2.0 Instrument is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by BioFire Diagnostics, LLC. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.