Promisemed Hangzhou Meditech Co., Ltd. FDA Record

Summary

Recent FDA inspections

1 inspection on Mar 13, 2015.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Recent 510(k) clearances

36 510(k) clearances from May 11, 2017 to Aug 25, 2026. Showing the 20 most recent. View all 36 510(k) clearances

Promisemed Hangzhou Meditech Co., Ltd. and the FDA: common questions

Has Promisemed Hangzhou Meditech Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Promisemed Hangzhou Meditech 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 Promisemed Hangzhou Meditech Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Promisemed Hangzhou Meditech Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Promisemed Hangzhou Meditech Co., Ltd.?

The most recent FDA inspection on file ended Mar 13, 2015 at Hangzhou, China and was classified NAI. FDA has 1 inspection of Promisemed Hangzhou Meditech Co., Ltd. on file.