Data / Medical devices / China / Beijing Unt Technology Co.,ltd
Beijing Unt Technology Co.,ltd: FDA-registered device maker in Beijing, China, 2 510(k) clearances
Beijing Unt Technology Co.,ltd is registered with the FDA (registration 3021380980) in Beijing, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 2, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3021380980
- Address
- M2-1 Area, Xinggu Development Zone, Pinggu District, Beijing, China, 101200
- Owner or operator
- Beijing UNT Technology Co.,Ltd (10083700)
- Roles
- Manufacturer
- First device listed
- December 13, 2021
- Registered through
- 2026
- Brand names listed
- Diode Laser Therapy Systems, Diode laser therapy system Zemits Quidion, Long Pulsed ND YAG Laser therapy device, Nd:Yag Laser Therapy Systems Yag Pro X, PicoCuter Laser Therapy Systems, PicoTitan Laser Therapy Systems, Zemits Quidion Lite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 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 |
|---|---|---|---|---|---|---|
| November 2, 2023 | K232532 | Nd:Yag Laser Therapy Systems | GEX | Substantially Equivalent | Beijing Unt Technology Co., Ltd. | accessdata.fda.gov |
| November 10, 2021 | K212978 | Diode laser therapy system | GEX | Substantially Equivalent | Beijing Unt Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 2, 2023. 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.