Bionit Labs Srl

FDA Regulatory Profile

Bionit Labs Srl appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 12, 2026.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)March 12, 2026
K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)January 2, 2025