Home / Companies / Guangzhou Berrcom Medical Device Co., Ltd.

Guangzhou Berrcom Medical Device Co., Ltd.

FDA Regulatory Profile

Guangzhou Berrcom Medical Device Co., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Apr 30, 2015 · VAI
Latest 510(k)
Jan 20, 2023

Reviewing Guangzhou Berrcom Medical Device 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.

Request a free FDA snapshot

Or get Guangzhou Berrcom Medical Device Co., Ltd.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Apr 30, 2015Guangzhou, ChinaDevicesVoluntary Action Indicated (VAI)3008395508

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
K214077Digital Thermometer, Model: DT007, DT008Jan 20, 2023
K213746Digital thermometer, Model DT101, DT102Apr 5, 2022
K213084Ear Thermometer, Model ET005, ET008, ET009Feb 25, 2022
K213079Ear Thermometer, Model ET001Feb 18, 2022
K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311Jan 28, 2022
K191570Infrared Thermometer Model MD-H30Nov 13, 2019

FDA data resources