Data / Medical devices / Single (Specified) Analyte Controls (Assayed And Unassayed) / Taiwan
FDA-registered makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in Taiwan: 11 establishments
11 establishments in Taiwan are registered with the FDA to make Single (Specified) Analyte Controls (Assayed And Unassayed) (product code JJX). 2 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
- Single (Specified) Analyte Controls (Assayed And Unassayed)
- Product code
- JJX
- Country
- Taiwan
Makers of Single (Specified) Analyte Controls (Assayed And Unassayed) in Taiwan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bionime Corporation | Taichung City, Taiwan | Manufacturer | 1 | October 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| Taidoc Technology Corporation | New Taipei City, Taiwan | Contract manufacturer, Manufacturer | 1 | July 29, 2010 | 0 | 0 | 0 | api.fda.gov |
| Alliance International Medical Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apex Biotechnology Corp. | HSINCHU Hsinchu(County), Taiwan | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eps Bio Technology Corp. | Hsinchu Hsinchu(County), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Instrumentation Corp. | New Taipei, Taiwan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Golden Smart Home Technology Corp. | Hsinchu City Hsinchu(City), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HMD Biomedical, Inc. | Hsinchu County Hsinchu(County), Taiwan | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ok Biotech Co., Ltd. | HSINCHU CITY Hsinchu(County), Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tyson Bioresearch, Inc. | Zhunan Township Miaoli, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Visgeneer, Inc. | HSINCHU CITY Hsinchu(City), Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.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.