FDA Registration
Active
🇨🇳 China
ClearVision Single Use Hysteroscope & Image Processing System
Reg #: 3028536560
·
FEI: 3028536560
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD
- Registration Number
- 3028536560
- FEI Number
- 3028536560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 688 Bin'an Road, Building 5, 12/F, Room 1208
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240401
Owner / Operator
- Firm Name
- OriGyn Medical Technology (Hangzhou) Co., Ltd
- Operator Number
- 10091314
- Address
- 688 Bin'an Road, Building 5, 12/F, Room 1208
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310051
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2024-08-21 |
Proprietary Names
ClearVision Single Use Hysteroscope & Image Processing System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device