# Curetis GmbH

- Location (FDA's records): Holzgerlingen, DE
- FDA decisions: 2 (2018–2019): 1 510(k) clearance and 1 De Novo grant
- Product codes: QBH (2)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Biofire Diagnostics, LLC: 1 (https://510kreport.com/company/biofire-diagnostics)

## Its most-cited devices
- DEN170047: Curetis Unyvero LRT Application (2018), cited by 2

## Recent decisions
- K191967: Unyvero LRT BAL Application (Dec 20, 2019)
- DEN170047: Curetis Unyvero LRT Application (Apr 3, 2018)

Source page: https://510kreport.com/company/curetis