FDA Registration
Active
🇨🇳 China
SURGICAL MICROSCOPE(model:EM-300), SM 1000 L, SM 3000 L, EM 600 B, SM 2000 J, EM 600 A, SM 2000 L, SM 1000 L/P
Reg #: 3014059828
·
FEI: 3014059828
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SHANGHAI EDER MEDICAL TECHNOLOGY INC.
- Registration Number
- 3014059828
- FEI Number
- 3014059828
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room430, Building4, No.512 Wenchuan Road, Baoshan District
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai Eder Medical Technology Inc.
- Operator Number
- 10056006
- Address
- Room430, Building4, No.512 Wenchuan Road, Baoshan District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 200433
- Country
- CN
- Correspondent
- Yilun Zheng
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2017-10-26 |
Proprietary Names
SURGICAL MICROSCOPE(model:EM-300), SM 1000 L, SM 3000 L, EM 600 B, SM 2000 J, EM 600 A, SM 2000 L, SM 1000 L/P
Stereo Optical Inverter, Stereo Indirect Ophthalmoscope
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device