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Unomedical Sdn. Bhd.

FDA Regulatory Profile

Unomedical Sdn. Bhd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection: Dec 6, 2012 · OAI

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	1	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	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 Sdn. Bhd. 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 S.R.O	Same company group	0	0	4	1	—

Recent FDA inspections

1 inspection on Dec 6, 2012.

Date	Site	Product	Classification	FEI
Dec 6, 2012	Sungai Petani, Kedah, Malaysia	Devices	Official Action Indicated (OAI)	3002806945

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.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002806945	Sungai Petani, Kedah, Malaysia	1	Dec 6, 2012

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