# Bittium Biosignals Ltd.

FEI: 1000425315
Status: Active
Establishment types: Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Owner/operator: Bittium Biosignals Ltd. (#9027486)

Address: PIONEERINKATU 6, KUOPIO Pohjois-Savo, 70800, FI

Mandatory US Agent: Emergo Global Representation LLC

## Products

Total registered: 3
Top product codes: DXH, DSI, MLO
Regulation §: 870.2920, 870.1025, 870.2800

Proprietary names: Bittium Faros 360 waterproof, Bittium Cardiac Explorer, Bittium Faros 180 waterproof, Faros Mobile, Faros14d, Bittium Cardiac Navigator

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%221000425315%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=1000425315