FDA Registration
Active
🇨🇳 China
Spinal orthosis S-TLSO-O-BV(BII)
Reg #: 3021970996
·
FEI: 3021970996
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Wuhan United Imaging Surgical Co., Ltd.
- Registration Number
- 3021970996
- FEI Number
- 3021970996
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Area A, United Imaging Wuhan Headquarters, No. 99 Gaokeyuan Rd., East Lake High-Tech Development Zone, Wuhan,
- City
- Wuhan Hubei
- Country
- CN
Owner / Operator
- Firm Name
- Wuhan United Imaging Healthcare Surgical Technology Co., Ltd
- Operator Number
- 10084336
- Address
- Area A, United Imaging Wuhan Headquarters, No. 99 Gaokeyuan Rd., East Lake High-Tech Development Zone, Wuhan,
- City
- Wuhan
- State
- Hubei
- Postal Code
- 430206
- Country
- CN
- Correspondent
- Fengshou He
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Thoracic | IPT | Class 1 | Physical Medicine | No | 2022-02-10 |
Proprietary Names
Spinal orthosis S-TLSO-O-BV(BII)
Spinal orthosis S-TLSO-O-BV(WI)
Spinal orthosis S-TLSO-O-BV(WII)
Spinal orthosis S-TLSO-O-BV(BI)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198