FDA Registration
Active
🇨🇳 China
Flexible Ureteroscope (US31A-12, US31B-12)
Reg #: 3015139943
·
FEI: 3015139943
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Shanghai AnQing Medical Instrument Co., Ltd
- Registration Number
- 3015139943
- FEI Number
- 3015139943
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3&4 Floor,No.2 Building, 366 Huiqing Rd , East Zhangjiang High-Tech Park
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K201293
Owner / Operator
- Firm Name
- Shanghai AnQing Medical Instrument CO., Ltd.
- Operator Number
- 10058112
- Address
- 3rd Floor, No.2 Building,, 366 Huiqing Rd , East Zhangjiang High-Tech Park
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201201
- Country
- CN
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2020-07-25 |
Proprietary Names
Flexible Ureteroscope (US31A-12, US31B-12)
Video Processor (EOS-B-01)
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device