Data / Medical devices / Taiwan / Brain Navi Biotechnology Co., Ltd.
Brain Navi Biotechnology Co., Ltd.: FDA-registered device maker in Zhubei City Hsinchu(County), Taiwan, 1 510(k) clearance
Brain Navi Biotechnology Co., Ltd. is registered with the FDA (registration 3015797559) in Zhubei City Hsinchu(County), Taiwan. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 23, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015797559
- Address
- No. 66-1, Shengyi 5th Rd., Zhubei City Hsinchu(County), Taiwan, 302
- Owner or operator
- BRAIN NAVI BIOTECHNOLOGY CO., LTD. (10081676)
- Roles
- Manufacturer
- First device listed
- May 12, 2021
- Registered through
- 2027
- Brand names listed
- NSR-P Automated Pipetting System, Stereotaxic Guiding Surgical Devices, NaoTrac S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
| Station, Pipetting And Diluting, For Clinical Use | JQW | 1 | 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 |
|---|---|---|---|---|---|---|
| May 23, 2025 | K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac S | HAW | Substantially Equivalent | Brain Navi Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Neurological Stereotaxic Instrument
- All makers of Station, Pipetting And Diluting, For Clinical Use
Updated May 23, 2025. 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.