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Unomedical S.R.O.

FDA Regulatory Profile

Unomedical S.R.O. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Unomedical S.R.O." and its spelling variant "Unomedical S.R.O". Records filed under related names are not included; see Related names.

Latest inspection: Oct 26, 2018 · NAI

Newer recall under related name Unomedical: Jul 23, 2024, Z-3186-2024.

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	4	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Unomedical S.R.O. above.

Name	Relation	Recalls	510(k)	Inspections	Compliance actions	Most recent recall
Unomedical	Same company group	13	22	3	0	Jul 23, 2024 (Z-3186-2024)
Unomedical Sdn. Bhd	Same company group	0	0	1	0	—

Recent FDA inspections

4 inspections from Jul 22, 2010 to Oct 26, 2018.

Date	Site	Product	Classification	FEI
Oct 26, 2018	Michalovce, Slovakia	Devices	No Action Indicated (NAI)	3005778470
Jan 29, 2015	Michalovce, Slovakia	Devices	No Action Indicated (NAI)	3005778470
Feb 6, 2014	Michalovce, Slovakia	Devices	Official Action Indicated (OAI)	3005778470
Jul 22, 2010	Michalovce, Slovakia	Devices	Voluntary Action Indicated (VAI)	3005778470

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

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Unomedical S.R.O.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 24, 2014.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3005778470	Michalovce, Slovakia	4	Oct 26, 2018

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