Automated Cryopreservation Storage System
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Guangdong and Jiangsu: 2 hold an FDA registration. 1 is a contract manufacturer.
- Guangzhou Pinzhi Medical Device Co., Ltd. Guangdong
- Jiangsu Kangjian Medical Apparatus Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
To provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm.
What Is FDA Product Code QUJ?
Automated Cryopreservation Storage System is FDA product code QUJ, Class 2, 21 CFR 884.6120.
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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