FDA Registration
Active
🇰🇷 South Korea
ZR75PN32
Reg #: 3009715136
·
FEI: 3009715136
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SG HEALTHCARE CO LTD
- Registration Number
- 3009715136
- FEI Number
- 3009715136
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 10, Yangnyeong-ro
- City
- Moga-myeon, Icheon-si Gyeonggi
- Country
- KR
Owner / Operator
- Firm Name
- SG Healthcare Co. Ltd
- Operator Number
- 10046997
- Address
- 10, Yangnyeong-ro
- City
- Moga-myeon, Icheon-si
- State
- Gyeonggi
- Postal Code
- 17408
- Country
- KR
US Agent
- Business Name
- Kamm & Associates
- Contact Name
- Daniel Kamm
- Address
- 8870 Ravello Ct
- City
- Naples
- State
- FL
- ZIP
- 34114
- Country
- US
- [email protected]
- Phone
- 239 4171727
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2018-08-14 |
Proprietary Names
ZR75PN32
ZR75PN40
ZR75PN50
ZR75PN65
ZR75PN80
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device