Data / Medical devices / Taiwan / DT Research, Inc Taiwan Branch
DT Research, Inc Taiwan Branch: FDA-registered device maker in New Taipei City, Taiwan, 1 510(k) clearance
DT Research, Inc Taiwan Branch is registered with the FDA (registration 3017233611) in New Taipei City, Taiwan. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 23, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017233611
- Address
- 6F., No.36 Wuquan 7th Rd. Wugu Dist., New Taipei City, Taiwan, 24890
- Owner or operator
- DT Research, Inc. (10076574)
- Roles
- Contract manufacturer, Exporter to the US
- First device listed
- July 23, 2020
- Registered through
- 2027
- Brand names listed
- Avvigo+
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Blood-Pressure | DSK | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Contract manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| July 23, 2020 | K201713 | AVVIGO Guidance System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Computer, Diagnostic, Programmable
- All makers of Computer, Blood-Pressure
Updated July 23, 2020. 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.