Absorbable Synthetic Wound Dressing
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Beijing and Guangdong.
- Beijing Kreate Medical Co., Ltd. Beijing
- Huizhou Foryou Medical Devices Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
How Is QSZ Classified?
Absorbable Synthetic Wound Dressing is FDA product code QSZ, unclassified.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 166 days from receipt to decision on them.
Name
Record