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Shenzhen Coreray Technology, Ltd.

FDA Regulatory Profile

Shenzhen Coreray Technology, Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 6, 2024 · NAI
Latest 510(k)
Sep 23, 2021

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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
Aug 6, 2024Shenzhen, ChinaDevicesNo Action Indicated (NAI)3014233600

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
K211747Reusable NIBP CuffSep 23, 2021
K192404Patient Monitoring Cable (SpO2 Extension Cable)Jun 22, 2020
K173368Reusable & Disposable SpO2 SensorsAug 31, 2018
K172797ECG Cable/LeadwiresFeb 28, 2018

FDA data resources