FDA Registration
Active
🇧🇪 Belgium
FEops HEARTguide
Reg #: 3020703662
·
FEI: 3020703662
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FEOPS NV
- Registration Number
- 3020703662
- FEI Number
- 3020703662
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Technologiepark-Zwijnaarde 122
- City
- Gent Oost-Vlaanderen
- Country
- BE
Regulatory Submissions
- 510(k) Number
- DEN200030
Owner / Operator
- Firm Name
- FEops NV
- Operator Number
- 10082838
- Address
- Technologiepark-Zwijnaarde 122
- City
- Gent
- State
- Oost-Vlaanderen
- Postal Code
- 9052
- Country
- BE
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interventional Cardiovascular Implant Simulation Software Device | QQI | Class 2 | Cardiovascular | No | 2021-10-07 |
Proprietary Names
FEops HEARTguide
FEops HEARTguide Simulation Application v1.4.2
Establishment Types
Manufacture Medical Device