FDA Registration
Active
🇨🇳 China
Photon Therapy Apparatus (model: BL-10)
Reg #: 3038197172
·
FEI: 3038197172
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
- Registration Number
- 3038197172
- FEI Number
- 3038197172
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1101/1102/1201/1202, Unit 1, Building 2, Hongpeng Building, Tiegang Community, Xixiang Street, Baoan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243993
Owner / Operator
- Firm Name
- Xemis Medical Technology (Shenzhen) Co., Ltd.
- Operator Number
- 10093075
- Address
- 1101/1102/1201/1202, Unit 1, Building 2, Hongpeng Building, Tiegang Community, Xixiang Street, Baoan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518102
- Country
- CN
- Correspondent
- Cecilia Yang
US Agent
- Business Name
- Dynasty Medical Consulting Inc.
- Contact Name
- Linda Chen
- Address
- 302 Round Lake Dr
- City
- Rosenberg
- State
- TX
- ZIP
- 77469
- Country
- US
- [email protected]
- Phone
- 832 3809688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-03-27 |
Proprietary Names
Photon Therapy Apparatus (model: BL-10)
Establishment Types
Manufacture Medical Device