Guangxi Hope Medical Devices Technology Co., Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • No warning letters matched by name
Inspections 0 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 1 Latest Oct 14, 2026

Guangxi Hope Medical Devices Technology Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Guangxi Hope Medical Devices Technology Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Guangxi Hope Medical Devices Technology Co., Ltd." and its spelling variant "Guangxi Hope Medical Devices Technology Co".

Latest 510(k)
Oct 14, 2026

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections0Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent 510(k) clearances

1 510(k) clearance on Oct 14, 2026.

K-NumberDeviceDate
K262885308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)Oct 14, 2026

Guangxi Hope Medical Devices Technology Co., Ltd. and the FDA: common questions

Has Guangxi Hope Medical Devices Technology Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Guangxi Hope Medical Devices Technology Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Guangxi Hope Medical Devices Technology Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Guangxi Hope Medical Devices Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

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