FDA device listing
Air Cooling Machine: GLD12,CO2 Laser Machine: GL063,GL070, GL080, GL090,Diode Laser Hair Removal Machine: GLD05, GLD06…
FDA device listing 1962457520 · Sanhe Meditech Co., Ltd
Key facts
| Proprietary names | Air Cooling Machine : GLD12,CO2 Laser Machine: GL063,GL070, GL080, GL090,Diode Laser Hair Removal Machine: GLD05, GLD06, GLD07, GLD08,GLD15, GLD17, GLD18,Diode Laser Hair Removal Machine: GLD21, GLD25, GLD26,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… |
|---|---|
| Owner/operator | Sanhe Meditech Co., Ltd |
| Owner/operator number | 10088569 |
| Product codes | NXF |
| Device names | NXF - Gas, Laser Generating |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SANHE MEDITECH CO., LTD |
| Establishment registrations | 3027851853 |
| FEI numbers | 3027851853 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database