Microrule, Ent
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Shandong.
- Xinhua Surgical Instrument Co., Ltd. Shandong
How Is KAH Classified?
Microrule, Ent is FDA product code KAH, Class 1, 21 CFR 874.4420.
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.