Sanhe Meditech Co., Ltd.
Manufacturer and brand owner in Sanhe, Hebei, China. 2 device types, 3 products catalogued, 3 clearances.
Sanhe Meditech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Gas, Laser Generating, Powered Laser Surgical Instrument. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
2device types registered with the FDA
3products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SANHE MEDITECH CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027851853 |
| FEI number | 3027851853 |
| DUNS | 443657496 |
| Establishment type | Manufacturer |
Location
| City | Sanhe |
|---|---|
| Province | Hebei |
| Address | Unit 3, Building 15, Zhongnan High Tech |
| Postal code | 065201 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Gas, Laser Generating | Class 1 | Facial Beauty Machine: GL001, GL002, GL003, GL005, GL006, GL007, GL008, GL009, GL010, GL012, GL015, GLY01, GLY02, GLY03, Diode Laser Hair Removal Machine: GLD05, GLD06, GLD07, GLD08,GLD15, GLD17, GLD18, Plasma Laser Beauty Machine: GL017, CO2 Laser Machine: GL063,GL070, GL080, GL090, Air Cooling Machine : GLD12, Picosecond Laser Machine: GL018, GL019, GL020, GL021, GL022, GL023, GL025, GL026, GL027, GL029 and 3 more | 2023 | 17 |
| Powered Laser Surgical Instrument | Class 2 | CO2 Laser System:GL060, GL062, GL065, GL066, GL067, GL068, Diode Laser Hair removal Machine: GLD01, GLD10, GLD16,GLD02,GLD03,GLD09,GLD19,GLD20,GLD22,GLD23, Nd YAG Laser Therapy Systems:GL022,GL028,GL030,GL036,GL037, GL038,GL039 | 2025 | 92 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Nd: YAG Laser Therapy Systems | GEX | 1 |
| Diode Laser Hair Removal Machine | GEX | 1 |
| CO2 Laser System | GEX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260375 | 2026-03-31 | GEX | Traditional | This company |
| K260257 | 2026-03-28 | GEX | Traditional | This company |
| K252427 | 2025-10-31 | GEX | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Sanhe Jumei Technology Co., Ltd. | 12 |
| Beijing Aeonmed Co., Ltd. | 7 |
| Hebei Zhemai Technology Co., Ltd. | 2 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.