B | 合法醫療器材資訊網

2020年9月21日—AboutB-TemiaInc.Foundedin2010,B-TemiaisaninnovativeCanadianroboticstechcompanythatdevelopsandmarketscutting-edge ...

B-Temia gains commercial access to the Taiwanese market

QUÉBEC CITY, Sept. 21, 2020 /PRNewswire/ - B-Temia Asia, a joint venture company between Wistron Medical Technology Company and B-Temia Inc. (the "Company") incorporated in November 2019, announces today that it obtained the Taiwanese Food and Drug Administration (TFDA) product license for its powered human mobility device "KeeogoTM. This license opens a new market and allows the Company to commercialize KeeogoTM in Taiwan, which represents one of the most important markets of the Asian territory. Last week, B-Temia Inc. obtained its 510(k) Clearance from the American Food and Drug Administration (FDA) as well as the CE Mark in December last year.

"The work we have accomplished for the last two years to prepare and obtain new regulatory approvals, such as the CE Mark and 510(k), paved the way to t...