SOFRADIM PRODUCTION

Listed in a source registry

France INSEE Sirene / INPI RNE state register (annuaire-entreprises.data.gouv.fr)

What is established and what is not

No researcher review has been written for this company yet. 21 official records from 13 official sources are on file. 4 other entries are not official records: our own technical checks and searches, open directory listings, our inferences or the company's own statements. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.

Facts on file, each with its evidence type

• inspection-follow-up (record type: inspection-follow-up) [official record; status green] Inspection 2026-03-23: 9 control points, 0 with follow-up: -. The inspector checked each regulatory point and wrote down which ones need a follow-up. A request for documents is an open question, not a proven breach; the report does not say how it was resolved later. checked 2026-10-20. Georisques, French register of classified installations (ICPE)
• On the company register (record type: registered-since) [official record; status green] On the company register since 1992. Shows how long the company has been on the state register, which is hard to fake and easy to check. effective since 2026-08-01. INSEE SIRENE (Registre national des entreprises)
• financials-published (record type: financials-published) [official record; status green] Annual accounts filed for 2025: revenue €99.8M, profit €32.6M. Lets you size the supplier against your own volume: the figure comes from accounts filed with the state, not from a claim on a website. effective since 2025-04-25. INPI/BCE published accounts (data.economie.gouv.fr)
• Street address on file in the state register (record type: registered-establishment) [official record; status green] The place of business the company itself declared when it registered. The register records the declaration; it does not inspect the site or show that anything is made there. effective since 2026-08-01. INSEE SIRENE (Registre national des entreprises)
• A change to the company's registration was published on the official record (record type: registry-change-published) [official record; status green] Indicates the register still receives filings from this company, so the record is maintained rather than abandoned. checked 2026-10-13. BODACC (annuaire-entreprises)
• No insolvency proceedings on record (record type: insolvency-clear) [our own observation, not an official record; status green] We searched the official bulletin and found no insolvency proceedings on that date. checked 2026-10-13. BODACC (annuaire-entreprises)
• The inspection report describes the site: La société SOFRADIM Production, appartenant au groupe MEDTRONIC, est implantée sur la commune de Trévoux (01). Elle a pour activité la fabrication et la commercialisation de prothèses. Le site de Trévoux emploie 450 personnes dont 100 personnes en recherche et développement. Le site a été initialement autorisé par arrêté préfectoral du 04 avril 2008. Suite à des évolutions substantielles de ses activités, une nouvelle demande d’autorisation d’exploiter a été déposée par l’exploitant, et a abouti à l’obtention d’un nouvel arrêté préfectoral d’autorisation environnementale le 10 septembre 2019. (record type: facility-activity-described) [official record; status green] The inspection report describes the site: La société SOFRADIM Production, appartenant au groupe MEDTRONIC, est implantée sur la commune de Trévoux (01). Elle a pour activité la fabrication et la commercialisation de prothèses. Le site de Trévoux emploie 450 personnes dont 100 personnes en recherche et développement. Le site a été initialement autorisé par arrêté préfectoral du 04 avril 2008. Suite à des évolutions substantielles de ses activités, une nouvelle demande d’autorisation d’exploiter a été déposée par l’exploitant, et a abouti à l’obtention d’un nouvel arrêté préfectoral d’autorisation environnementale le 10 septembre 2019.. A state inspector wrote this after standing on the site, so it describes what the plant actually does, not what its own website claims. checked 2026-10-20. Georisques, French register of classified installations (ICPE)
• Listed in the national industrial register as an industrial site (record type: industrial-site-registered) [official record; status green] The country's industrial register lists this company as holding a working industrial establishment, with its own registry number and activity code. A trading office does not get one. Open the source for the entry. effective since 2024-12-31. IREP, French register of pollutant releases and waste (declared by the operator)
• Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 15 medical devices: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) (K253956, 2026-05-21), Parietene™ Macroporous Mesh (PPM5050 ) (K250869, 2025-04-23), ProGrip™ Self-Gripping Polypropylene Mesh (K243315, 2025-01-17) +12. The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
• Named directors on file (record type: directors-on-file) [official record; status green] 3 directors on file. The register names the people who run the company, so there is someone answerable if something goes wrong. checked 2026-07-26. INSEE Sirene (annuaire-entreprises)
• EU customs identifier (EORI) active (record type: export-registered-eori) [official record; status green] An EORI number identifies the company to EU customs for imports, exports and transit. A valid number does not show that any shipment took place and is not a licence to export a particular product. checked 2026-07-26. EU EORI validation (European Commission)
• Registered with the U.S. FDA (active, renewed for the current year) (record type: fda-registered) [official record; status green] Registered with the US food and drug regulator, renewed for the current year. checked 2026-07-26. FDA
• Mentioned in independent media (record type: media-mention) [our own observation, not an official record; status green] The press has written about it. A fact, not an endorsement. effective since 2018-10-07. leprogres.fr
• No match found in the debarment registers we checked (record type: debarment-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public debarment datasets and found no matching candidate. Absence from these lists is a search result, not a certificate. checked 2026-07-26. OpenSanctions
• No match found on the sanctions lists we checked (record type: sanctions-clear) [our own observation, not an official record; name search, no matching candidate] We searched the public sanctions datasets and found no matching candidate. A name search is not full compliance screening. checked 2026-07-26. OpenSanctions
• Files its annual accounts, latest on public record (record type: bodacc-accounts-filed) [official record; status green] Annual accounts filed for 2025 Matched to this company by name only; no second anchor confirms it is the same legal entity.. Indicates the company still meets its reporting duties. checked 2026-10-13. BODACC (annuaire-entreprises)
• Registry ID checks out with the state register (record type: registry-id-verified) [official record; status green] Helps confirm the company on this page is the same legal entity as in the register. effective since 2026-07-22. Annuaire des Entreprises (INSEE / INPI)
• Street address on file in the state register (record type: registered-address) [official record; status green] The address the company itself gave the register, so post and inspectors reach it there. checked 2026-08-10. INSEE Sirene (annuaire-entreprises)
• Workforce size in the company register (record type: workforce-on-record) [official record; status green] Between 250 and 499 employees on the state record. One indication of the company's size as the register records it; it does not establish production capacity. effective since 2026-07-01. INSEE SIRENE (Registre national des entreprises)
• EU VAT number valid for cross-border trade (record type: vat-valid) [official record; status green] The number is registered and active: we asked the EU VIES service and it answered yes. An invalid VAT number is the first sign an invoice comes from the wrong company. checked 2026-07-26. VIES
• Legally registered and still active (record type: registry-active-global) [official record; status green] Shows the register lists the registration as active on the date we read it. It does not show how busy the business is. checked 2026-10-15. France INSEE Sirene state register (data.gouv.fr bulk file)
• registry-activity (record type: registry-activity) [official record; status green] Activity code in the state register: NAF 32.50A. Shows what the state itself says the company does, which you can compare with what it promises you. checked 2026-10-15. France INSEE Sirene state register (data.gouv.fr bulk file)
• Operating permit for the production site (record type: operating-permit) [official record; status green] Shows an authority issued a permit for an installation at this site for the activity named in the record. A permit is not an inspection report and not an observation that production is running today. checked 2026-08-31. Georisques, French register of classified installations (ICPE)
• A state inspector visited the site, on the official record (record type: facility-inspected) [official record; status green] Inspected 2026-03-23. An inspector came to the site on that date, so the site existed then and was not only licensed on paper. The visit itself does not show what was being made there. checked 2026-10-23. Georisques, French register of classified installations (ICPE)

Government supervision

Supervision records found: 1 site(s) under a permit, 0 other site(s) on the register, 3 dated inspection(s). A permit or a register entry is not an inspection; each record is listed above with its source.

Relationships

4 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.

Recorded in a source

• 3 more officer(s), not named in the record: Officer in the register. INSEE Sirene (annuaire-entreprises)
• 116 AVENUE DE FORMANS 01600 TREVOUX: Site named in the record. INSEE SIRENE (Registre national des entreprises)
• 116, avenue Formans, 01600 Trévoux: Holds the site's permit. Georisques, French register of classified installations (ICPE)
• SOFRADIM PRODUCTION: Site named in the record. IREP, French register of pollutant releases and waste (declared by the operator)

Import rules for these goods

• Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
• For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)

Check independently

• Sanctions and watchlists (OpenSanctions)
• VAT number check (EU VIES)