Mectronic Medicale S.R.L.

FDA Regulatory Profile

Mectronic Medicale S.R.L. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
Feb 27, 2025 · VAI
Latest 510(k)
Feb 17, 2023

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 27, 2025Grassobbio, ItalyDevicesVoluntary Action Indicated (VAI)3015283772

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K221043Doctor Tecar Plus, Doctor Tecar SmartFeb 17, 2023
K183693Doctor TecarFeb 22, 2019