FDA Registration
Active
🇨🇳 China
Hoover Negative Pressure Access Sheath(IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250)
Reg #: 3032859397
·
FEI: 3032859397
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- INNOVEX MEDICAL CO., LTD.
- Registration Number
- 3032859397
- FEI Number
- 3032859397
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China, 1st, 2nd Floor, No.14 Building and 3rd, 4th Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243820
Owner / Operator
- Firm Name
- INNOVEX MEDICAL CO., LTD.
- Operator Number
- 10092290
- Address
- 2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201201
- Country
- CN
- Correspondent
- Alice Wang
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-02-07 |
Proprietary Names
Hoover Negative Pressure Access Sheath(IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250)
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device