FDA Registration
Active
🇰🇷 South Korea
SAMSUNG MEDISON CO., LTD.
Reg #: 3009758186
·
FEI: 3009758186
·
Expires 2026
Products
5
Proprietary Names
126
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- SAMSUNG MEDISON CO., LTD.
- Registration Number
- 3009758186
- FEI Number
- 3009758186
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 244, 1gongdan-ro
- City
- Gumi-si Gyeongbuk
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K151663
Owner / Operator
- Firm Name
- SAMSUNG MEDISON CO., LTD.
- Operator Number
- 8041160
- Address
- 3366, Hanseo-ro, Nam-myeon,
- City
- Hongcheon-gun
- State
- Gangwon
- Postal Code
- 25108
- Country
- KR
- Correspondent
- Lisa Jang
US Agent
- Business Name
- Samsung HME America, Inc.
- Contact Name
- Ninad Gujar
- Address
- 14 Electronics Ave
- City
- Danvers
- State
- MA
- ZIP
- 01923
- Country
- US
- [email protected]
- Phone
- 978 5648632
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2015-08-13 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2015-08-13 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2015-08-13 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2025-02-14 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-02-14 |
Proprietary Names
RS80A
HS40
HS50 / HS60 Diagnostic Ultrasound System
UGEO WS80A
HERA W10 Diagnostic Ultrasound System
RS85
RS80 EVO
RS85 Diagnostic Ultrasound System
RS85 Ultrasound System
RS80 EVO System
RS80 evo Diagnostic Ultrasound System
RS80 evo System
V6 Diagnostic Ultrasound System
V8 Diagnostic Ultrasound System
V7 Diagnostic Ultrasound System
HM70 EVO
ACCUVIX XG
HERA W10
HERA W9
HS30 System
HS30 Ultrasound System
SONOACE R7
cV7 Diagnostic Ultrasound System
cV6 Diagnostic Ultrasound System
cV8 Diagnostic Ultrasound System
UGEO HM70A
HM70A
EKO 7
cV4 Diagnostic Ultrasound System
V5 Diagnostic Ultrasound System
cV5 Diagnostic Ultrasound System
V4 Diagnostic Ultrasound System
WS80A
WS80A Diagnostic Ultrasound System
V7
V8
A35
ACCUVIX A30
H6
V6
H8
H7
HERA W9 Diagnostic Ultrasound System
EVO XQ10 Diagnostic Ultrasound System
EVO Q30 Diagnostic Ultrasound System
EVO XQ20 Diagnostic Ultrasound System
EVO Q10 Diagnostic Ultrasound System
EVO Q20 Diagnostic Ultrasound System
EVO QH20 Diagnostic Ultrasound System
EVO XQ30 Diagnostic Ultrasound System
EVO QH30 Diagnostic Ultrasound System
EVO QH10 Diagnostic Ultrasound System
HS50 Diagnostics Ultrasound System
HS60 Diagnostics Ultrasound System
HS50/HS60 Diagnostics Ultrasound System
SONOACE R5
MySono U6
HS30 Diagnostic Ultrasound System
HS60
HS50
5D Viewer
hera I10 Diagnostic Ultrasound System
HERA I10 Diagnostic Ultrasound System
I10 Diagnostic Ultrasound System
HS40 Diagnostic Ultrasound System
H60
RS85 Prestige
HS70A Diagnostic Ultrasound System
HS70A
HS40 Ultrasound System
HS40 System
HS40 diagnostic ultrasound system
UGEO H60
UGEO PT60A
PT60A
RS85 Prestige Diagnostic Ultrasound System
3D/5D Viewer
SONOACE R3
HERA Z20
HERA Z30
R20
R30
Z20
HERA Z20s
HERA Z20e
R30 Diagnostic Ultrasound System
R26 Elite Diagnostic Ultrasound System
HERA W20 Plus Diagnostic Ultrasound System
R20 Plus Diagnostic Ultrasound System
R30 Plus Diagnostic Ultrasound System
XR20 Diagnostic Ultrasound System
HERA W12 Plus Diagnostic Ultrasound System
R26 Exp Diagnostic Ultrasound System
HERA XW12 Diagnostic Ultrasound System
R26 Diagnostic Ultrasound System
HERA Z20 Diagnostic Ultrasound System
HERA W20 Diagnostic Ultrasound System
XR26 Diagnostic Ultrasound System
HERA XW30 Diagnostic Ultrasound System
R30 Elite Diagnostic Ultrasound System
HERA XZ20 Diagnostic Ultrasound System
R20 Diagnostic Ultrasound System
R30 Exp Diagnostic Ultrasound System
HERA Z20s Diagnostic Ultrasound System
HERA Z20e Diagnostic Ultrasound System
HERA W30 Diagnostic Ultrasound System
HERA W30 Elite Diagnostic Ultrasound System
R20 Exp Diagnostic Ultrasound System
HERA W12 Elite Diagnostic Ultrasound System
HERA XZ30 Diagnostic Ultrasound System
HERA W30 Plus Diagnostic Ultrasound System
HERA W20 Elite Diagnostic Ultrasound System
R20 Elite Diagnostic Ultrasound System
HERA XW20 Diagnostic Ultrasound System
R26 Plus Diagnostic Ultrasound System
HERA W12 Diagnostic Ultrasound System
XR30 Diagnostic Ultrasound System
HERA Z30 Diagnostic Ultrasound System
HM70A Diagnostic Ultrasound System
HS70A System
H4 Diagnostic Ultrasound System
XH4 Diagnostic Ultrasound System
XH5 Diagnostic Ultrasound System
XV5 Diagnostic Ultrasound System
XV4 Diagnostic Ultrasound System
H5 Diagnostic Ultrasound System
Establishment Types
Manufacture Medical Device