# Miris AB

- Location (FDA's records): Uppsala, SE
- FDA decisions: 2 (2018–2023): 1 510(k) clearance and 1 De Novo grant
- Product codes: QEI (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
- Lactation Lab, Inc.: 1 (https://510kreport.com/company/lactation-lab)

## Its most-cited devices
- DEN180007: Miris Human Milk Analyzer (2018), cited by 2

## Recent decisions
- K223085: Miris Human Milk Analyzer (HMA) (Sep 29, 2023)
- DEN180007: Miris Human Milk Analyzer (Dec 21, 2018)

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