FDA Registration
Active
🇨🇳 China
Sinobot X1
Reg #: 3027616024
·
FEI: 3027616024
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sinovation (Beijing) Medical Technology Co., Ltd
- Registration Number
- 3027616024
- FEI Number
- 3027616024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Rm 401, Bld 12-1, No.26 Yongwang West Road, Z-park Daxing
- City
- Beijing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K220072
Owner / Operator
- Firm Name
- Sinovation (Beijing) Medical Technology Co., Ltd
- Operator Number
- 10088361
- Address
- 1st Floor, Building 6, No. 69, Qingfeng West Road, Z-park Daxing Bio-medicine Industry Park, Daxing District,
- City
- Beijing
- State
- CN-BJ
- Postal Code
- 102600
- Country
- CN
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2023-07-14 |
Proprietary Names
Sinobot X1
Establishment Types
Manufacture Medical Device