FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

GUDID Database Mostly Contains Class II and Implantable Devices

April 13, 2018
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Nearly 80 percent of the 1.6 million medical devices registered in the FDA’s Global Unique Identification Database are Class II medical devices and nearly half are implantable devices, the FDA reported.

Roughly 43 percent of medical devices fall under this category and include devices such as powered wheelchairs and pregnancy test kits.

Approximately half of the devices in the database are implantable devices, the FDA said in a new report. 

Of the implantable devices in the database, more than 35 percent are orthopedic devices, followed by dental devices, general and plastic surgery devices, cardiovascular, and general hospital devices.

Devicemakers are required to submit data to the Global Unique Device Identification Database under the unique device identification system requirements to better identify and track medical devices.

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