FDA Registration
Active
🇫🇷 France
TRINITY/3D PROSTATE SUITE
Reg #: 3008487708
·
FEI: 3008487708
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- KOELIS
- Registration Number
- 3008487708
- FEI Number
- 3008487708
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 22 Chemin du Vieux Chene
- City
- MEYLAN Isere
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K170521
Owner / Operator
- Firm Name
- KOELIS
- Operator Number
- 10033933
- Address
- 22 Chemin du vieux chene
- City
- MEYLAN
- State
- Isere
- Postal Code
- 38240
- Country
- FR
- Correspondent
- Antoine LEROY
US Agent
- Business Name
- Axelia Partners LLC
- Contact Name
- Alexandra SUHAS
- Address
- 185 Alewife Brook Parkway, Suite 210
- City
- Cambridge
- State
- MA
- ZIP
- 02138
- Country
- US
- [email protected]
- Phone
- 617 8525333
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2017-08-18 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2017-08-18 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2017-08-18 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2017-08-18 |
Proprietary Names
TRINITY/3D PROSTATE SUITE
Establishment Types
Manufacture Medical Device