Retractor, Ophthalmic
Who Makes This Device Type in China?
8 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Shandong and Shanghai. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Asol Co., Ltd. Jiangsu
- Belle Healthcare Technology Co., Ltd. Jiangsu
- Huaian Tisurg Medical Instruments Co., Ltd. Jiangsu, contract manufacturer
- Huaian Wolfram Surgical Instruments Jiangsu
- Malosa Medical Instruments (Changshu) Limited Jiangsu, contract manufacturer
- Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
- Suzhou Virgil Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Xinhua Surgical Instrument Co., Ltd. Shandong
How Is HNI Classified?
Retractor, Ophthalmic is FDA product code HNI, Class 1, 21 CFR 886.4350.
How Does It Reach the US Market?
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.
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