FDA Registration
Active
🇧🇪 Belgium
Lifestent and Lifestent XL Vascular Stent System and lifestent solo vascular stent system
Reg #: 3005941719
·
FEI: 3002807111
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sterigenics Belgium Petit Rechain S.A.
- Registration Number
- 3005941719
- FEI Number
- 3002807111
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zoning Industriel de Petit-Rechain, Avenue Andre Ernst 21
- City
- Verviers Liege
- Country
- BE
Regulatory Submissions
- PMA Number
- P070014
Owner / Operator
- Firm Name
- Sotera Health LLC
- Operator Number
- 10029425
- Address
- 2015 Spring Road, Suite 650
- City
- Oak Brook
- State
- IL
- Postal Code
- 60523
- Country
- US
- Correspondent
- Karen Whaley-Krumins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stent, Superficial Femoral Artery | NIP | Class 3 | Unknown | No | 2013-02-07 |
Proprietary Names
Lifestent and Lifestent XL Vascular Stent System and lifestent solo vascular stent system
LifeStent Solo Vascular Stent System
LifeStent 5F Vascular Stent System
Lifestent and Lifestent XL Vascular Stent System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)