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Jiangxi Sanxin Medtec Co., Ltd.

FDA Regulatory Profile

Jiangxi Sanxin Medtec Co., Ltd. has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 25, 2025 · NAI
Latest 510(k)
Sep 6, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances3Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 25, 2025Nanchang, ChinaDevicesNo Action Indicated (NAI)3005246939
Jul 31, 2014Nanchang, ChinaDevicesVoluntary Action Indicated (VAI)3005246939

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 3005246939Nanchang, China2Jun 25, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K202796SANSIN Tubing Sets for HemodialysisSep 6, 2021
K202719Disposable Medical Face MasksJan 4, 2021
K142797I.V. CatheterJun 18, 2015

FDA data resources

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