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Smartdata Suzhou Co., Ltd.

FDA Regulatory Profile

Smartdata Suzhou Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 31, 2017 · NAI
Latest 510(k)
Sep 6, 2019

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 31, 2017Suzhou, ChinaDrugsNo Action Indicated (NAI)3008058134

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
K191366Vacutore Air/Water Bottle TubingSep 6, 2019
K191231Andorate Auxiliary Water Connector, Andorate Valves SetJun 7, 2019
K182998Andorate Auxiliary Water ConnectorApr 17, 2019
K181509Endorate Valve SetsJul 6, 2018

FDA data resources