Data / Medical devices / Mask, Surgical / Taiwan
FDA-registered makers of Mask, Surgical in Taiwan: 8 establishments
8 establishments in Taiwan are registered with the FDA to make Mask, Surgical (product code FXX). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Mask, Surgical
- Product code
- FXX
- Country
- Taiwan
Makers of Mask, Surgical in Taiwan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Modern Healthcare Corp. | TIEN CHUNG COUNTY, CHANG-HWA Changhua, Taiwan | Exporter to the US, Manufacturer | 2 | August 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| Acme Filter Mask Inc. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 1 | May 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Aero Pro Co., Ltd. | CHANG HUA HSIEN Changhua, Taiwan | Exporter to the US, Manufacturer | 1 | July 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Angeline Group Ltd. | New Taipei City, Taiwan | Manufacturer | 1 | August 5, 2011 | 0 | 0 | 0 | api.fda.gov |
| China Surgical Dressings Center Co.,ltd | CHANGHWA CITY, FU-TIEN LI Changhua, Taiwan | Manufacturer, Repackager or relabeler | 1 | October 26, 2005 | 0 | 0 | 0 | api.fda.gov |
| R&R Medical Corporation Ltd. | Sanchong District New Taipei, Taiwan | Foreign private label distributor, Manufacturer, Repackager or relabeler | 1 | September 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Manufacturer | 1 | September 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Medicom Asia-Pacific Holdings Limited. Taiwan Branch | Wujie Township Yilan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.