FDA Registration
Active
🇫🇷 France
AZMED SAS
Reg #: 3026753394
·
FEI: 3026753394
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- AZMED SAS
- Registration Number
- 3026753394
- FEI Number
- 3026753394
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10 Rue D'Uzes
- City
- Paris
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K220164
Owner / Operator
- Firm Name
- AZmed
- Operator Number
- 10087096
- Address
- 10 Rue d'Uzes
- City
- Paris
- State
- Ile-de-France
- Postal Code
- 75002
- Country
- FR
- Correspondent
- Anthony JOSEPH
US Agent
- Business Name
- leanRAQA
- Contact Name
- Michelle Lott
- Address
- 131 E Loch Lomond
- City
- Oro Valley
- State
- AZ
- ZIP
- 85737
- Country
- US
- [email protected]
- Phone
- 520 2759838
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer Assisted Detection/Diagnosis Software For Fracture | QBS | Class 2 | Radiology | No | 2023-01-24 |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | Class 2 | Radiology | No | 2026-04-15 |
| Analyzer, Medical Image | MYN | Class 2 | Radiology | No | 2026-04-15 |
Proprietary Names
Rayvolve
Rayvolve PTX-PE
Rayvolve LN
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198