FDA Registration
Active
🇰🇷 South Korea
INTOPS CO.,LTD.
Reg #: 3014886121
·
FEI: 3014886121
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTOPS CO.,LTD.
- Registration Number
- 3014886121
- FEI Number
- 3014886121
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 97, Sanup-Ro, Gwonseon-ward
- City
- Suwon Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K172935
Owner / Operator
- Firm Name
- INTOPS Co.,Ltd.
- Operator Number
- 10059242
- Address
- 97, Sanup-Ro, Gwonseon-ward
- City
- Suwon
- State
- Gyeonggi
- Postal Code
- 16642
- Country
- KR
- Correspondent
- Jong su Lee
US Agent
- Business Name
- Empatica Inc.
- Contact Name
- Matteo Lai
- Address
- 1 Broadway,
- City
- Cambridge
- State
- MA
- ZIP
- 02142
- Country
- US
- [email protected]
- Phone
- 415 5483860
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Physiological Signal Based Seizure Monitoring System | POS | Class 2 | Neurology | No | 2018-12-14 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)