FDA Registration
Active
🇫🇷 France
SIMAGEC
Reg #: 3010462278
·
FEI: 3010462278
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIMAGEC
- Registration Number
- 3010462278
- FEI Number
- 3010462278
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 54 avenue de la Plaine, Z.I.
- City
- ROUSSET CEDEX Bouches-du-Rhone
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K172465
Owner / Operator
- Firm Name
- SIMAGEC
- Operator Number
- 10045012
- Address
- 54 avenue de la Plaine, Z.I.
- City
- ROUSSET CEDEX
- State
- Bouches-du-Rhone
- Postal Code
- 13106
- Country
- FR
- Correspondent
- Gaelle RIVIERE
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-12-01 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)