Data / Medical devices / Taiwan / Nanoray Biotech Co., Ltd.
Nanoray Biotech Co., Ltd.: FDA-registered device maker in Taipei City, Taiwan, 1 510(k) clearance
Nanoray Biotech Co., Ltd. is registered with the FDA (registration 3014293172) in Taipei City, Taiwan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014293172
- Address
- 7F, No. 91, Xinhu 1st Rd., Taipei City, Taiwan, 11494
- Owner or operator
- NanoRay Biotech Co., LTD. (10086253)
- Roles
- Manufacturer
- First device listed
- October 25, 2022
- Registered through
- 2026
- Brand names listed
- Revolux,Hand Diagnostic Radiography Imaging System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, X-Ray, Stationary | KPR | 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 |
|---|---|---|---|---|---|---|
| April 29, 2022 | K220271 | Hand Diagnostic Radiography Imaging System | KPR | Substantially Equivalent | Nanoray Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 29, 2022. 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.