Timer, General Laboratory
Which Manufacturers in China Make This?
5 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Zhejiang and Shandong. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Diatrust Medical Co., Ltd. Jiangsu
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Ningbo Castle Medical Import & Export Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Ningyuan Import & Export Co., Ltd. Zhejiang, contract manufacturer
- Qingdao Unison Industries Co., Limited Shandong
What Is FDA Product Code JBS?
Timer, General Laboratory is FDA product code JBS, Class 1, 21 CFR 862.2050.
What Does It Take to Sell It in the United States?
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. It is also exempt from most of the quality system regulation.
What Has Gone Wrong With It?
The FDA has recorded 2 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Device Design (1) and Mixed-up of materials/components (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
O-Two
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