FDA Registration
Active
🇧🇪 Belgium
Tutopatch® Bovine Pericardium
Reg #: 3004681519
·
FEI: 3003870583
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Sterigenics Belgium Fleurus SA
- Registration Number
- 3004681519
- FEI Number
- 3003870583
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zoning Industrial de Fleurus, Avenue De L Esperance, 17
- City
- Fleurus Hainaut
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K991296
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 |
|---|---|---|---|---|---|
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2013-10-28 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2013-10-28 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2013-10-28 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2013-10-28 |
Proprietary Names
Tutopatch® Bovine Pericardium
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)