Hemostatic Wound Dressing Without Thrombin or Other Biologics
Who Makes This Device Type in China?
10 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Beijing and Guangdong, and 3 other provinces. 2 of them are contract manufacturers, able to build to a buyer’s own specification.
- Beijing Huan QIU LI Kang Biotech Co., Ltd. Beijing, contract manufacturer
- Bestreat Safety & First AID Solution Co., Ltd. Hubei
- Beijing Taikesiman Technology Development Co., Ltd. Beijing, contract manufacturer
- Emsrun Group Jiangsu
- Hangzhou ZEO-Innov Life Technology Co., Ltd. Zhejiang
- Huizhou Foryou Medical Devices Co., Ltd. Guangdong, contract manufacturer
- Jiangsu Newvalue Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Shenzhen JPY ION-Tech. Co., Ltd. Guangdong, contract manufacturer
- Taizhou Xinkang Medical Materials Co., Ltd. Jiangsu, contract manufacturer
- Xiamen Firstcare IMP. & EXP. Co., Ltd. Fujian
What Is This Device?
To temporarily control bleeding and cover external wounds.
How Is QSY Classified?
Hemostatic Wound Dressing Without Thrombin Or Other Biologics is FDA product code QSY, 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 5 clearances under this code; the FDA took a median of 265 days from receipt to decision on them.
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