Sterilizer, Tonometer
Who Makes This Device Type in China?
6 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Beijing and Guangdong, and 2 other provinces. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Beijing Hongdee Corporation Beijing
- Changsha Yingtai Instrument Co., Ltd. Hunan
- Dongguan Aobo Technology Co., Ltd. Guangdong
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Jiangyin Binjiang Medical Equipment Co., Ltd. Jiangsu
- Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Shaanxi, contract manufacturer
How Is HKZ Classified?
Sterilizer, Tonometer is FDA product code HKZ, Class 1, 21 CFR 886.1940.
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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