Sofradim Production
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Sofradim Production is a medical device manufacturer, with 326 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and III; EU Class III) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 326
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 267
- EUDAMED 143
- FDA 510(k) 43
- Device classes
- FDA Class II 308
- EU Class III 16
- FDA Class III 2
- Top EMDN categories
- FDA recalls
- Sites and related companies
- Sofradim Production France
- Identifiers
- DUNS 576342646
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 326 devicesShowing 1-50 of 326
Company details
- DUNS number
- 576342646
- Phone
- +1(508)261-8000
FDA recalls
FDA recall records list 1 recall initiated by SOFRADIM PRODUCTION, initiated on 2018-02-23. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 23 Feb 2018 Z-1523-2018 Class II Terminated There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
Full distribution text
- 23 Feb 2018 Z-1523-2018 Class II Terminated There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.
Sites
- Sofradim Production FRFEI 3003521774 18 devices
Frequently asked questions
How many devices does SOFRADIM PRODUCTION have in the registry?
The registry currently lists 326 devices for SOFRADIM PRODUCTION. Devices recorded under merged duplicate company entries are counted once.
Which registries list SOFRADIM PRODUCTION's devices?
Among its 50 most recently registered devices, SOFRADIM PRODUCTION has devices listed in EUDAMED (31 devices), FDA 510(k) (2 devices) and FDA GUDID (32 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do SOFRADIM PRODUCTION's devices fall under?
Among its 50 most recently registered devices, the classes recorded for SOFRADIM PRODUCTION's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for SOFRADIM PRODUCTION?
FDA recall records list 1 recall initiated by SOFRADIM PRODUCTION, the most recent initiated on 23 Feb 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from SOFRADIM PRODUCTION in the registry?
The most recently registered devices listed for SOFRADIM PRODUCTION include Transorb™ Self-Gripping Resorbable Mesh (TSB1510), ProGripTM, ParieteneTM and ParietexTM.