Shenzhen Medke Technology Co., Ltd.

FDA Regulatory Profile

Shenzhen Medke Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 13, 2025 · VAI
Latest 510(k)
Jun 20, 2025

Reviewing Shenzhen Medke Technology Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Shenzhen Medke Technology Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

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
Inspections1Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 13, 2025Shenzhen, ChinaDevicesVoluntary Action Indicated (VAI)3012804266

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 3012804266Shenzhen, China1Jun 13, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106…Jun 20, 2025
K242623Disposable Blood Pressure cuff; Reusable Blood Pressure cuffOct 31, 2024
K152390Medke Oximetry Finger SensorAug 18, 2016

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