Implant, Auditory Brainstem
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Shanghai. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Jabil Circuit (Shanghai) Ltd. Shanghai, contract manufacturer
How Is MHE Classified?
Implant, Auditory Brainstem is FDA product code MHE, 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.
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