Data / Medical devices / Taiwan / Rossmax International Ltd.
Rossmax International Ltd.: FDA-registered device maker in Taipei, Taiwan, 2 510(k) clearances
Rossmax International Ltd. is registered with the FDA (registration 9680548) in Taipei, Taiwan. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 4, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680548
- FEI number
- 3003247551
- Address
- 12F., No.189, Kang Chien RD., Taipei, Taiwan, 114
- Owner or operator
- ROSSMAX INTERNATIONAL LTD. (9009721)
- Roles
- Specification developer
- First device listed
- November 19, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Specification developer | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| April 4, 2006 | K060342 | ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K | DXN | Substantially Equivalent | Rossmax International , Ltd. | accessdata.fda.gov |
| February 3, 2006 | K053006 | ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II | DXQ | Substantially Equivalent | Rossmax Internationl , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Pressure Cuff
- All makers of Stethoscope, Manual
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated April 4, 2006. 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.