FDA Registration
Active
🇨🇳 China
Diode Laser Therapy System
Reg #: 3016453004
·
FEI: 3016453004
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sanhe LEFIS Electronics Co.,Ltd
- Registration Number
- 3016453004
- FEI Number
- 3016453004
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 11 #1-101, Phase 1, Zhongnan High tech Yanjiao Science and Technology Innovation Smart Valley Indust
- City
- langfang Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K192569
Owner / Operator
- Firm Name
- Sanhe LEFIS Electronics Co.,Ltd
- Operator Number
- 10062323
- Address
- Building 11 #1-101, Phase 1, Zhongnan High tech Yanjiao Science and Technology Innovation Smart Valley Indust
- City
- langfang
- State
- Hebei
- Postal Code
- 065201
- Country
- CN
- Correspondent
- Dandan wang
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., LTD
- Contact Name
- Marco Mu Mu
- Address
- 2219 Rimland Drive, Suite 301,
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-01-12 |
Proprietary Names
Diode Laser Therapy System
Establishment Types
Manufacture Medical Device