Data / Medical devices / China / Triangel RSD Limited
Triangel RSD Limited: FDA-registered device maker in Baoding Hebei, China, 1 510(k) clearance
Triangel RSD Limited is registered with the FDA (registration 3027605646) in Baoding Hebei, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027605646
- Address
- Room 1701, 17th Floor, Zhibo Technology Comprehensive Research And Development Building, 89 Hengbin Road, Baoding, Hebei, China, Baoding Hebei, China, 071000
- Owner or operator
- TRIANGEL RSD LIMITED (10088216)
- Roles
- Manufacturer
- First device listed
- June 11, 2023
- Registered through
- 2026
- Brand names listed
- Diode laser therapy device, ENDO MINI, ENDO ONE, ENDO PRO, ENDO UP, ENDOAGE, JUNERA, LASEEV and more
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 |
|---|---|---|---|---|---|---|
| June 6, 2023 | K212734 | Diode laser therapy device | GEX | Substantially Equivalent | Triangel Rsd Limited | accessdata.fda.gov |
Compare with other makers
Updated June 6, 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.