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Ningbo Shun YE Medical Company, Ltd.

FDA Regulatory Profile

Ningbo Shun YE Medical Company, Ltd. has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 12, 2016 · NAI
Latest 510(k)
Jun 27, 2022

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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) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 12, 2016Cixi Ningbo, ChinaDevicesNo Action Indicated (NAI)3009103001

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
K213786CiRX Single use electrosurgical pencil with non-coated and coated electrodeJun 27, 2022
K210256CiRx (R) Surgical MaskAug 19, 2021

FDA data resources