MetriGuard
Catalogue number 10-7506, listed by Metrex Research, United States, under Disinfectant, Medical Devices. 197 manufacturers in China are registered for this product code.
197 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Guangdong and Jiangsu, and 17 other provinces. 17 of them are contract manufacturers, able to build to a buyer’s own specification.
Disinfectant, Medical Devices is FDA product code LRJ, Class 1, 21 CFR 880.6890.
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.
The FDA has recorded 17 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Environmental control (3), Process control (2) and Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Catalogue number 10-7506, listed by Metrex Research, United States, under Disinfectant, Medical Devices. 197 manufacturers in China are registered for this product code.
Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.