Data / Medical devices / Taiwan / Taiwan Scientific Corporation
Taiwan Scientific Corporation: FDA-registered device maker in New Taipei, Taiwan, 2 510(k) clearances
Taiwan Scientific Corporation is registered with the FDA (registration 3042928308) in New Taipei, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 7, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042928308
- Address
- 10th Floor Room 4 Number 88 Ming Chiuan Road, New Taipei, Taiwan, 23141
- Owner or operator
- Taiwan Scientific Corporation (10094834)
- Roles
- Manufacturer
- First device listed
- December 28, 2025
- Registered through
- 2026
- Brand names listed
- ANSWatcch Mini, ANSWatch, HRVWatch, HRVWatch Mini
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 7, 2021 | K201914 | HRVWatch-Mini Wrist Monitor | DXN | Substantially Equivalent | Taiwan Scientific Corporation | accessdata.fda.gov |
| September 17, 2013 | K123130 | ANSWATCH WRIST MONITOR MODEL TS-0411 | DXN | Substantially Equivalent | Taiwan Scientific Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Transmitters And Receivers, Electrocardiograph, Telephone
- All makers of Electrocardiograph
Updated June 7, 2021. 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.