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Bittium Biosignals Ltd.

FEI 1000425315 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number1000425315
Owner / OperatorBittium Biosignals Ltd. (#9027486)
AddressPIONEERINKATU 6, KUOPIO Pohjois-Savo, 70800, FI
Mandatory US AgentEmergo Global Representation LLC
Registration expiry2026
Initial importer flagN
Registered products3
Product codes (top 20)DXH, DSI, MLO
Regulation § (21 CFR)870.2920, 870.1025, 870.2800
Proprietary namesBittium Faros 360 waterproof; Bittium Cardiac Explorer; Bittium Faros 180 waterproof; Faros Mobile; Faros14d; Bittium Cardiac Navigator

External sources

Source: openFDA. Public-domain (CC0).