Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District, Beijing, China, 101300
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| CO2 LASER THERAPY SYSTEMS | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| CO2 Laser Therapy Systems (SHE-LSP003-1) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Cryojet Plus (SHE-ACP001-1) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Diode Laser Hair Removal System | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| Diode Laser Hair Removal System for Medical Use | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| EMS Muscle Stimulation System | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| General/Multiple Surgical Carbon Dioxide Laser System (CO2 Laser) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
| HI-EMT MAGSHAPE | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| LumiGlam Laser System (SHE-LSP601-3) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Q-SWITCHED ND:YAG LASER | Not registered with US (FDA) | Not registered with UK (MHRA) | Registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Q-Switched Nd:YAG Laser (SHE-LSP101-1) | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | AU (TGA): manufacturer registered, device not confirmed | Not registered with EU (EUDAMED) |
| Surgical Frequency-Doubled Nd:YAGLaser System (Pico Laser) | Not registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Registered with AU (TGA) | Not registered with EU (EUDAMED) |
Get alerts on new registrations, recalls, and regulatory changes.
