FDA Registration
Active
🇨🇳 China
Disposable Hysteroscope System
Reg #: 3021610866
·
FEI: 3021610866
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Suzhou Acuvu Medical Technology Co., Ltd.
- Registration Number
- 3021610866
- FEI Number
- 3021610866
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B1-212, Bio-Nano Park, 218 Xinghu St. Suzhou Industrial Park
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K231260
Owner / Operator
- Firm Name
- Process Control Services
- Operator Number
- 10083910
- Address
- 318 Bluefish Court
- City
- Foster City
- State
- CA
- Postal Code
- 94404
- Country
- US
- Correspondent
- Sam Mostafavi
US Agent
- Business Name
- Process Control Services
- Contact Name
- Sam Mostafavi
- Address
- 318 Bluefish Court
- City
- Foster City
- State
- CA
- ZIP
- 94404
- Country
- US
- [email protected]
- Phone
- 650 6706972
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2024-03-07 |
Proprietary Names
Disposable Hysteroscope System
Establishment Types
Manufacture Medical Device