FDA Registration
Active
🇨🇳 China
Infrared Light Therapy Device
Reg #: 3022553912
·
FEI: 3022553912
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- OMEDIC TECHNOLOGY (DONGGUAN) CO., LTD
- Registration Number
- 3022553912
- FEI Number
- 3022553912
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 302, Building 1, No.8, Shizhai Road, Chang'an Town
- City
- Dongguan Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Omedic Technology (Dongguan) Co., Ltd
- Operator Number
- 10084669
- Address
- Room 302, Building 1, No.8, Shizhai Road, Chang'an Town
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523850
- Country
- CN
- Correspondent
- xiaoli Tan
US Agent
- Business Name
- UGK-LVM UNITED INC
- Contact Name
- jimmy chen
- Address
- 6547 N Academy Blvd #2266
- City
- Co Spgs
- State
- CO
- ZIP
- 80918
- Country
- US
- [email protected]
- Phone
- 323 5104660
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-12-20 |
Proprietary Names
Infrared Light Therapy Device
Red Light Therapy Device
M01,M02,M04,M05,M06,M07,M08,M09,M10
Body Red Light Therapy
Elite 78,Elite 150,Elite 300,Pro 78,Pro 150,Pro 300,Basic 78,Basic 150,Basic 300,Core 78,Core 150,Core 300,
Infrared Lamp Panel
OMP01,OMP02,OMP03,OMP04,OMP05,OMP06.
PotonBeam Pro,PotonBeam Basic,PotonBeam Elite,OMH01,OMH02,OMH03,OMH04, OMH05 ,OMH06
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Manufacture Medical Device