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Euromi S.A

FDA Regulatory Profile

Euromi S.A has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 1 compliance action on record.

Latest inspection
Jul 31, 2025 · VAI
Latest 510(k)
Dec 16, 2010

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 31, 2025Dison, BelgiumDevicesVoluntary Action Indicated (VAI)3007697975
Jan 15, 2015Dison, BelgiumDevicesOfficial Action Indicated (OAI)3007697975

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3007697975Dison, Belgium2Jul 31, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K101413EUROMI EVA SP6Dec 16, 2010
K010311LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICEJun 29, 2001

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.