Tianjin Empecs Medical Device Co., Ltd.

FDA Regulatory Profile

Tianjin Empecs Medical Device Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 28, 2016 · NAI
Latest 510(k)
Jun 7, 2017

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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 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 28, 2016Tianjin, ChinaDevicesNo Action Indicated (NAI)3003116995

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
K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System…Jun 7, 2017
K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring…Mar 21, 2017
K133260MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEMJun 27, 2014
K111456MEDISIGN BLOOD GLUCOSE MONITORING SYSTEMFeb 28, 2012