FDA Registration
Active
🇫🇷 France
A01038 - 3D Offset Imaging Set SPX1
Reg #: 3021060474
·
FEI: 3021060474
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ECENTIAL ROBOTICS
- Registration Number
- 3021060474
- FEI Number
- 3021060474
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1
- City
- Gieres Isere
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K220946
Owner / Operator
- Firm Name
- Ecential Robotics
- Operator Number
- 10084446
- Address
- 2 avenue de Vignate, Zone de Mayencin II Parc Equation Batiment 1
- City
- Gieres
- State
- Isere
- Postal Code
- 38610
- Country
- FR
- Correspondent
- Elodie bouillet
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2022-12-14 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2022-12-14 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2022-12-14 |
Proprietary Names
A01038 - 3D Offset Imaging Set SPX1
Establishment Types
Manufacture Medical Device