Implant, Cochlear
Who Makes This Device Type in China?
All 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are based in Guangdong and Shanghai.
- IN-Tech Electronics Ltd Guangdong, contract manufacturer
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
- Mehow Innovative (Huizhou) Ltd. Guangdong, contract manufacturer
- Mehow Innovative Ltd Guangdong, contract manufacturer
- Zhong Shan First City Leather Products Co., Ltd. Guangdong, contract manufacturer
What Is FDA Product Code MCM?
Implant, Cochlear is FDA product code MCM, Class 3.
How Does It Reach the US Market?
A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.
What Do the Recalls Say?
The FDA has recorded 32 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Process control (5), Employee error (4) and Device Design (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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