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Data / Medical devices / Strap, Head, Gas Mask / Taiwan

FDA-registered makers of Strap, Head, Gas Mask in Taiwan: 11 establishments

11 establishments in Taiwan are registered with the FDA to make Strap, Head, Gas Mask (product code BTK). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Strap, Head, Gas Mask
Product code
BTK
Country
Taiwan

Makers of Strap, Head, Gas Mask in Taiwan

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Acare Technology Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
Besmed Health Business CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Enter Medical CorporationChiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Foremount Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Foxxmed LtdIlan Yilan, TaiwanManufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Hsiner Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Maxhealth Corp.Xizhi District, New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Taroko Intl. Co., Ltd.Jen-Te, Tainan, TaiwanManufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.