FDA Registration
Active
🇫🇷 France
Owandy-RX PRO
Reg #: 9615832
·
FEI: 3003026827
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OWANDY RADIOLOGY
- Registration Number
- 9615832
- FEI Number
- 3003026827
- Status
- Active
- Expiry Year
- 2025
- 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
- K132378
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 |
|---|---|---|---|---|---|
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2022-07-26 |
Proprietary Names
Owandy-RX PRO
Establishment Types
Repack or Relabel Medical Device