FDA Registration
Active
🇨🇳 China
XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
Reg #: 3038197172
·
FEI: 3038197172
·
Expires 2026
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- XEMIS MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD.
- Registration Number
- 3038197172
- FEI Number
- 3038197172
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5th Floor, Building 369, Baotian 1st Road, Tiegang Community, Xixiang Street, Baoan
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K244041
Owner / Operator
- Firm Name
- Xemis Medical Technology (Shenzhen) Co., Ltd.
- Operator Number
- 10093075
- Address
- 5th Floor,Building 369, Baotian 1st Road, Tiegang Community, Xixiang Street, Baoan
- 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 |
|---|---|---|---|---|---|
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2025-11-24 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2025-11-24 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2025-11-24 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2025-11-24 |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | Class 2 | Physical Medicine | No | 2025-11-24 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-03-27 |
Proprietary Names
Ultrasound Therapy Workstation
Photon Therapy Apparatus (model: BL-10)
Establishment Types
Manufacture Medical Device