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Sign in to claim this brandSOFRADIM PRODUCTION
US
Last updated May 24, 2026
What SOFRADIM PRODUCTION makes
The company manufactures extra-gynaecological surgical meshes, including composite-polymer, synthetic polymer (both non-bioabsorbable and bioabsorbable), and collagen-based bioabsorbable variants. These products are designed for surgical applications requiring tissue reinforcement or repair, such as hernia repair or pelvic organ prolapse correction. Device examples include Parietex, ProGrip, Symbotex, Versatex, Parietene DS, and Parietene.
The portfolio consists of devices classified as Class II and Class III under regulatory frameworks, with submissions documented via FDA 510(k) and FDA Unique Device Identification (UDI) listings. These products are authorised for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sofradim Production manufacture?
Sofradim Production specialises in extra-gynaecological surgical meshes, which are used primarily for tissue reinforcement or repair in procedures like hernia repair or pelvic organ prolapse correction. Their portfolio includes meshes made from composite polymers, synthetic polymers (both non-bioabsorbable and bioabsorbable), and collagen-based bioabsorbable materials without antimicrobial properties.
Where is Sofradim Production based, and where are their devices authorised for use?
Sofradim Production is headquartered in the United States. Their devices are authorised for use in the US, where regulatory submissions—such as FDA 510(k) clearances and FDA Unique Device Identification (UDI) listings—are documented. This reflects the company’s focus on compliance with US regulatory requirements.
Which regulatory registries or databases list Sofradim Production’s devices?
Sofradim Production’s devices are documented in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track submissions and classifications required for device authorisation in the US, ensuring transparency in their regulatory status.
How are Sofradim Production’s devices classified under regulatory frameworks?
Sofradim Production’s devices fall into two regulatory classes: Class II and Class III. Class II devices typically pose moderate risk and require special controls beyond general controls, while Class III devices are higher-risk and generally require premarket approval due to insufficient data to assure safety and effectiveness through other means. The classification depends on factors like the device’s intended use and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- covidien.com
- —
- —
- [email protected]
- Phone
- +1(508)261-8000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 576342646
Catalogue (296)
Page 4 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Parietene | PPM1508X3 | FDA UDI | Class II | Active |
| Permacol | P151520 | FDA UDI | Class II | Active |
| Symbotex | SYM3020 | FDA UDI | Class II | Active |
| Parietene | PPM1106X3 | FDA UDI | Class II | Active |
| ProGrip | TEM1515G | FDA UDI | Class II | Active |
| Permacol | P152050 | FDA UDI | Class II | Active |
| Permacol | P101520 | FDA UDI | Class II | Active |
| Parietex | PCO12X | FDA UDI | Class II | Active |
| Parietex | TECT1510ADP2L | FDA UDI | Class II | Active |
| ProGrip | TEM1208GR | FDA UDI | Class II | Active |
| Enduragen | 89221 | FDA UDI | Class II | Active |
| Permacol | P100205 | FDA UDI | Class II | Active |
| Parietex | PCO3020X | FDA UDI | Class II | Active |
| Parietex | PCO15FX | FDA UDI | Class II | Active |
| Parietex | PCO2520X | FDA UDI | Class II | Active |
| Versatex | VTX1515M | FDA UDI | Class II | Active |
| Parietex | TECR1410DP2 | FDA UDI | Class II | Unknown |
| Symbotex | SYM2015 | FDA UDI | Class II | Active |
| ProGrip | LPG1510AK2 | FDA UDI | Class II | Unknown |
| ProGrip | TEM1208GL | FDA UDI | Class II | Active |
| Dextile | DXT1309AR | FDA UDI | Class II | Active |
| ProGrip | TEM1509G | FDA UDI | Class II | Active |
| Parietene | PPM3030 | FDA UDI | Class II | Active |
| Parietene DS | PPDS3020 | FDA UDI | Class II | Active |
| ProGrip | TEM2015G | FDA UDI | Class II | Active |
| Symbotex | SYM2015OS | FDA UDI | Class II | Active |
| Parietene DS | PPDS12 | FDA UDI | Class II | Active |
| Versatex | VTX3030M | FDA UDI | Class II | Active |
| Parietex | TECT1510ADP2R | FDA UDI | Class II | Active |
| Versatex | VTX4530M | FDA UDI | Class II | Active |
| Parietex | TET1510 | FDA UDI | Class II | Active |
| ProGrip | LPG1614 | FDA UDI | Class II | Active |
| Symbotex | SYM3020OS | FDA UDI | Class II | Active |
| Parietex | TECT1309AR | FDA UDI | Class II | Active |
| Parietene | PPM4530X3 | FDA UDI | Class II | Active |
| ProGrip | LPG1510AL | FDA UDI | Class II | Active |
| ProGrip | LPG1309AR | FDA UDI | Class II | Active |
| Symbotex | SYM3020F | FDA UDI | Class II | Active |
| Parietex | TECR3030 | FDA UDI | Class II | Active |
| Parietene | PPM2020 | FDA UDI | Class II | Active |
| Duatene | DTN07RX3 | FDA UDI | Class II | Active |
| Versatex | VTX5050M | FDA UDI | Class II | Active |
| Transorb | TSB3030 | FDA UDI | Class II | Active |
| Parietex | TET1309D | FDA UDI | Class II | Active |
| Permacol | P152830 | FDA UDI | Class II | Unknown |
| Symbotex | SYM12F | FDA UDI | Class II | Active |
| Parietene | PPMK1508 | FDA UDI | Class II | Active |
| Parietex | TECT1612AR | FDA UDI | Class II | Active |
| Parietex | PNP8X3 | FDA UDI | Class II | Active |
| Symbotex | SYM2012E | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Sofradim Production TREVOUX Auvergne-Rhone-Alpes · FR FEI 3003521774