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SOFRADIM 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
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(508)261-8000
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
576342646

Catalogue (296)

Page 6 of 6
DeviceModel / ReferenceRegistriesClassStatus
Parietex TCM2020
FDA UDI
Class IIUnknown
Parietene DS PPDS2015
FDA UDI
Class IIActive
Parietex TET3030
FDA UDI
Class IIActive
Transorb TSB4030
FDA UDI
Class IIActive
Permacol P100204
FDA UDI
Class IIActive
Progrip Laparoscopic Self-Fixating Mesh K143386
FDA 510(k)
Class IIActive
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh K142900
FDA 510(k)
Class IIActive
Parietene Macroporous Mesh K142091
FDA 510(k)
Class IIActive
Transorb™ Self-Gripping Resorbable Mesh K233661
FDA 510(k)
Class IIActive
Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh K140941
FDA 510(k)
Class IIActive
Ugytex Sual Knit Mesh K051503
FDA 510(k)
Class IIIActive
Versatex Monofilament Mesh K150091
FDA 510(k)
Class IIActive
Parie Tene Progrip Mesh K101197
FDA 510(k)
Class IIActive
Parietex Composite Pco-Os And Pco-Ob Meshes K050187
FDA 510(k)
Class IIActive
Prevadh Mesh K073287
FDA 510(k)
Class IIActive
Parietex Monofilament Polyester Mesh K090858
FDA 510(k)
Class IIActive
Symbotex(tm) Composite Mesh K131969
FDA 510(k)
Class IIActive
Parietex Plug And Patch K101519
FDA 510(k)
Class IIActive
Progrip Laparoscopic Self-Fixating Mesh K123479
FDA 510(k)
Class IIActive
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) K173796
FDA 510(k)
Class IIActive
Parietex Progrip K103682
FDA 510(k)
Class IIActive
Ugytex Mesh K033376
FDA 510(k)
Class IIActive
Dextile Anatomical Mesh K192443
FDA 510(k)
Class IIActive
Parietex Polyester Mesh With Introducer K071629
FDA 510(k)
Class IIActive
Pairetex Optimized Composite Mesh (pco-Fx Refrences) K110663
FDA 510(k)
Class IIActive
Parietex Optimized Compostie Mesh K110815
FDA 510(k)
Class IIActive
Parietex Composite Ventral Patch K120506
FDA 510(k)
Class IIActive
ProGrip™ Self-Gripping Polypropylene Mesh K243315
FDA 510(k)
Class IIActive
Progrip Laparscopic Self-Fixating Mesh K120897
FDA 510(k)
Class IIActive
Parietex Optimized Composite Mesh (pco-Osx References) K110816
FDA 510(k)
Class IIActive
Uretex Sup Pubourethral Sling K012949
FDA 510(k)
Class IIActive
Parietene™ Macroporous Mesh (PPM5050 ) K250869
FDA 510(k)
Class IIActive
Pariefix K032093
FDA 510(k)
Class IIActive
Modification To Parietex Composite (pco) Mesh K040998
FDA 510(k)
Class IIActive
Parietene Macroporous Mesh K223218
FDA 510(k)
Class IIActive
Parietene Duo And Quadra Polypropylene Meshes K072951
FDA 510(k)
Class IIIActive
Progrip™ Self-Gripping Polypropylene Mesh K232373
FDA 510(k)
Class IIActive
Sofradim Parietex Surgical Meshes K003990
FDA 510(k)
Class IIActive
Parietex Composite Mono Pm Mesh K081126
FDA 510(k)
Class IIActive
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh K142908
FDA 510(k)
Class IIActive
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh K220586
FDA 510(k)
Class IIActive
Parietex Progrip Mesh K081050
FDA 510(k)
Class IIActive
Duatene bilayer mesh K172395
FDA 510(k)
Class IIActive
Parietene Polypropylene Mesh K991400
FDA 510(k)
Class IIActive
Parietene DS Composite Mesh K163212
FDA 510(k)
Class IIActive
Uretex To Trans-Obturator Urethral Support System K041176
FDA 510(k)
Class IIActive

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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