FDA Registration
Active
🇫🇷 France
OWANDY RADIOLOGY
Reg #: 9615832
·
FEI: 3003026827
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OWANDY RADIOLOGY
- Registration Number
- 9615832
- FEI Number
- 3003026827
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Rue des vieilles vignes, Marne la Vallée
- City
- CROISSY-BEAUBOURG Seine-et-Marne
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K201382
Owner / Operator
- Firm Name
- OWANDY RADIOLOGY
- Operator Number
- 9042115
- Address
- 2 rue des vieilles vignes, --
- City
- CROISSY-BEAUBOURG
- State
- Seine-et-Marne
- Postal Code
- 77183
- Country
- FR
- Correspondent
- Eric - FAUVARQUE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2020-12-09 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2020-12-09 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2014-07-08 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2015-10-05 |
Proprietary Names
I-MAX 3D
Opteo
ONE
Ow-RX
NPR1000AA
Owandy-CR
I-MAX
I-MAX Touch 3D
Owandy-RX DC
Owandy-RX PRO
I-MAX Touch
OwandyCam
Establishment Types
Repack or Relabel Medical Device