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Bionit Labs Srl
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K260453
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
March 12, 2026
K242326
Wave Electrode (AE02-60); Wave Electrode (AE02-50)
January 2, 2025