FDA Registration
Active
🇨🇳 China
portable slit lamp microscope-KJ5S1 KJ5S2 KJ5S3 KJ5S4
Reg #: 3015169067
·
FEI: 3015169067
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SUZHOU KANGJIE MEDICAL INC.
- Registration Number
- 3015169067
- FEI Number
- 3015169067
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 15,No.2 Shuangma Street,Weiting Town,Suzhou Industrial Park
- City
- suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K162778
Owner / Operator
- Firm Name
- Suzhou Kangjie Medical Inc.
- Operator Number
- 10059464
- Address
- Building 15,No.2 Shuangma Street,Weiting Town,Suzhou Industrial Park
- City
- suzhou
- State
- Jiangsu
- Postal Code
- 215121
- Country
- CN
- Correspondent
- Hong Zhu
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2019-01-28 |
Proprietary Names
portable slit lamp microscope-KJ5S1 KJ5S2 KJ5S3 KJ5S4
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)