FDA Registration
Active
🇫🇷 France
SOFRADIM PRODUCTION
Reg #: 9615742
·
FEI: 3003521774
·
Expires 2026
Products
6
Proprietary Names
24
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SOFRADIM PRODUCTION
- Registration Number
- 9615742
- FEI Number
- 3003521774
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 116 AVENUE DU FORMANS
- City
- TREVOUX Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K220586
Owner / Operator
- Firm Name
- Covidien llc
- Operator Number
- 1282497
- Address
- 15 HAMPSHIRE STREET, --
- City
- Mansfield
- State
- MA
- Postal Code
- 02048
- Country
- US
US Agent
- Business Name
- Covidien LLC
- Contact Name
- Marsha Seetaram
- Address
- 15 Hampshire Street
- City
- Mansfield
- State
- MA
- ZIP
- 02048
- Country
- US
- [email protected]
- Phone
- 904 2812763
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2022-06-29 |
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | Class 2 | General, Plastic Surgery | No | 2018-02-08 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2014-05-15 |
| Surgical Film | OOD | Class 2 | General, Plastic Surgery | No | 2024-02-14 |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | Class 2 | General, Plastic Surgery | No | 2024-02-14 |
| Mesh, Surgical, Collagen, Large Abdominal Wall Defects | OXK | Class 2 | General, Plastic Surgery | No | 2014-05-15 |
Proprietary Names
Parietex 2D 3D Anatomical Mesh
Symbotex Composite Mesh
Progrip Self-Gripping Polyester Mesh
Versatex Monofilament Mesh
ProGrip Self-Gripping Polypropylene Mesh
Progrip self-gripping polypropylene mesh
Parietene DS Composite Mesh
Dextile Anatomical Mesh
Permacol Surgical Implant US
Parietex Plug and Patch System
ProGrip Self-Gripping Polyester Mesh
ProGrip Laparoscopic Self-Fixating Mesh
ParieteneTM Macroporous Mesh
Parietex 2D 3D Anatomical Mesh
ENDURAGen Collagen Implant
Parietex Composite Ventral Patch
Transorb Self-Gripping Resorbable Mesh
ProGrip advanced self-gripping polypropylene mesh
Parietene Flat Sheet Mesh
Parietene Macroporous Mesh
Parietex Composite Mesh
Parietex Optimized Composite Mesh
Parietex Composite Parastomal Mesh
ProGrip Self-Gripping Polypropylene Mesh
Establishment Types
Manufacture Medical Device