Data / Medical devices / China / Sanhe Meditech Co., Ltd
Sanhe Meditech Co., Ltd: FDA-registered device maker in Sanhe Hebei, China, 3 510(k) clearances
Sanhe Meditech Co., Ltd is registered with the FDA (registration 3027851853) in Sanhe Hebei, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 31, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027851853
- Address
- Unit 3, Building 15, Zhongnan High Tech No.4 Liushan Street, Yanjiao, Sanhe Hebei, China, 065201
- Owner or operator
- Sanhe Meditech Co., Ltd (10088569)
- Roles
- Manufacturer
- First device listed
- August 17, 2023
- Registered through
- 2026
- Brand names listed
- Air Cooling Machine : GLD12, CO2 Laser Machine: GL063,GL070, GL080, GL090, CO2 Laser System:GL060, GL062, GL065, GL066, GL067, GL068, Diode Laser Hair Removal Machine: GLD05, GLD06, GLD07, GLD08,GLD15, GLD17, GLD18, Diode Laser Hair Removal Machine: GLD21, GLD25, GLD26, Diode Laser Hair removal Machine: GLD01, GLD10, GLD16,GLD02,GLD03,GLD09,GLD19,GLD20,GLD22,GLD23, Facial Beauty Machine: GL001, GL002, GL003, GL005, GL006, GL007, GL008, GL009, GL010, GL012, GL015, GLY01, GLY02, GLY03, Facial Beauty Machine: GLC01, GLC02, GLC03, GLC05, GLC16, GLQ01, GLQ02, GLQ03, GLP03 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gas, Laser Generating | NXF | 1 | Manufacturer | accessdata.fda.gov |
| 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 |
|---|---|---|---|---|---|---|
| March 31, 2026 | K260375 | Nd: YAG Laser Therapy Systems | GEX | Substantially Equivalent | Sanhe Meditech Co., Ltd. | accessdata.fda.gov |
| March 28, 2026 | K260257 | CO2 Laser System | GEX | Substantially Equivalent | Sanhe Meditech Co., Ltd. | accessdata.fda.gov |
| October 31, 2025 | K252427 | Diode Laser Hair Removal Machine (GLD01) | GEX | Substantially Equivalent | Sanhe Meditech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 31, 2026. 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.