FDA Registration
Active
🇫🇷 France
BALT EXTRUSION
Reg #: 8023054
·
FEI: 3004216185
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- BALT EXTRUSION
- Registration Number
- 8023054
- FEI Number
- 3004216185
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10 RUE DE LA CROIX VIGNERON
- City
- MONTMORENCY Val-d'Oise
- Country
- FR
Owner / Operator
- Firm Name
- BALT EXTRUSION
- Operator Number
- 8023054
- Address
- 10 RUE CROIX VIGNERON
- City
- MONTMORENCY
- State
- Val-d'Oise
- Postal Code
- 95160
- Country
- FR
- Correspondent
- David Vu
US Agent
- Business Name
- Balt USA, LLC
- Contact Name
- David Vu
- Address
- 29 Parker
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 7881443
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2008-01-08 |
| Guide, Wire, Catheter, Neurovasculature | MOF | Class 2 | Cardiovascular | No | 2019-06-30 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-06-30 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2020-01-07 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2020-01-07 |
Proprietary Names
Magic
HYBRID Guidewire
Eclipse 2L Occlusion Balloon Catheter
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)