Beads, Hydrophilic, for Wound Exudate Absorption

Who Makes This Device Type in China?

7 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Anhui and Henan. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Dongyang City Yonoel Outdoor Products Co., Ltd. Zhejiang, contract manufacturer
H&K International Trade Limited (China) Zhejiang, contract manufacturer
Henan Huibo Medical Co., Ltd. Henan, contract manufacturer
Planet (Anhui) International Co., Ltd. Anhui
Wenzhou Zhusi Medical Supplies Co., Ltd. Zhejiang, contract manufacturer
Yiwu EO Sterilization Technology Co., Ltd. Zhejiang, contract manufacturer
Yiwu Ori-Power Medtech Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code KOZ?

Beads, Hydrophilic, For Wound Exudate Absorption is FDA product code KOZ, Class 1, 21 CFR 878.4018.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Beads, Hydrophilic, For Wound Exudate Absorption