BioMerieux

What is established and what is not

No researcher review has been written for this company yet. 21 official records from 15 official sources are on file. 6 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

• First recorded on the web archive (record type: web-presence-since) [our own observation, not an official record; status green] The company website was already online in 1998. Shows a web archive saw a page at this address on that date. It does not show who ran the site then. checked 2026-08-21. Internet Archive (Wayback)
• Workforce size in the company register (record type: workforce-on-record) [official record; status green] Between 2000 and 4999 employees on the state record. Tells you whether the supplier can realistically take on your volume. effective since 2026-08-01. INSEE SIRENE (Registre national des entreprises)
• On the company register (record type: registered-since) [official record; status green] On the company register since 1967. 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)
• 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)
• An environmental inspector visited the plant, on the official record (record type: facility-inspected) [official record; status green] Inspected 2025-12-01. 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 2026-10-13. Georisques, French register of classified installations (ICPE)
• Authorised Economic Operator in the EU customs register (record type: aeo-certified) [official record; status green] Customs granted trusted-trader status after auditing its procedures. checked 2026-08-30. EU AEO register (European Commission)
• 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 2026-08-26. EU EORI validation (European Commission)
• Active legal entity ID (LEI) (record type: lei-active) [official record; status green] A global identifier used in finance; an active one is renewed yearly. checked 2026-09-07. GLEIF global LEI register (golden copy)
• Line of business as recorded in the state register: 20.59Z (record type: registry-activity) [official record; status green] Shows what the state itself says the company does, which you can compare with what it promises you. effective since 2026-08-01. INSEE SIRENE (Registre national des entreprises)
• The inspection report describes the site: Le site BIOMERIEUX de Marcy l’Étoile est spécialisé dans la fabrication de réactifs nécessaires à la réalisation de tests biologiques, destinés à être utilisés par les différents systèmes de diagnostics in vitro conçus, développés et commercialisés par BIOMERIEUX. Le site est classé à autorisation pour la rubrique 2681 (mise en œuvre de micro-organismes naturels pathogènes dans des installations de production industrielle). (record type: facility-activity-described) [official record; status green] The inspection report describes the site: Le site BIOMERIEUX de Marcy l’Étoile est spécialisé dans la fabrication de réactifs nécessaires à la réalisation de tests biologiques, destinés à être utilisés par les différents systèmes de diagnostics in vitro conçus, développés et commercialisés par BIOMERIEUX. Le site est classé à autorisation pour la rubrique 2681 (mise en œuvre de micro-organismes naturels pathogènes dans des installations de production industrielle).. 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 2026-10-13. Georisques, French register of classified installations (ICPE)
• Places goods on the market (national producer register) (record type: places-goods-on-market; this record does not by itself establish manufacturing) [official record; status green] A state register lists this company as placing these goods on the market, as their maker or importer. By itself it does not show who makes them. checked 2026-09-07. Registre national des producteurs (ADEME/SYDEREP), France
• 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)
• Legally registered and still active (record type: registry-active-global) [official record; status green] Indicates the company is not dissolved or winding down. checked 2026-08-19. INSEE Sirene (annuaire-entreprises)
• inspection-follow-up (record type: inspection-follow-up) [official record; status amber] Inspection 2025-12-01: 6 control points, 5 with follow-up: Situation administrative: proposed Demande de justificatif à l'exploitant (request to the operator for supporting documents), 2 mois; Liste micro-organismes pathogènes: proposed Demande de justificatif à l'exploitant, Demande d'action corrective (request to the operator for supporting documents), 3 mois; OGM - Décision de classement du Haut Conseil en Biotechnologie: proposed Demande de justificatif à l'exploitant, Demande d'action corrective (request to the operator for supporting documents), 2 mois; OGM viables hors confinement: proposed Demande de justificatif à l'exploitant, Demande d'action corrective (request to the operator for supporting documents), 3 mois; Accident Sérum Humain: proposed Demande de justificatif à l'exploitant, Demande d'action corrective (request to the operator for supporting documents), 15 jours. 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 2026-10-13. Georisques, French register of classified installations (ICPE)
• 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 2026-08-26. FDA
• 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 2026-08-26. 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 2026-08-26. OpenSanctions
• Business email on the company's own domain (record type: corporate-mail-on-domain) [our own observation, not an official record; status green] Shows the domain runs its own email rather than a free mailbox. It describes the domain, not who owns it. checked 2026-08-26. Mail server of the company domain
• Market access approved: European Union (record type: market-access-eu) [official record; status green] Shows the establishment is approved for the listed activities under the EU food-hygiene rules and appears in the EU list of approved establishments. It is not an import check and not an observation of current production. checked 2026-08-22. TRACES NT, European Commission register of approved establishments (DG SANTE)
• 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)
• 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. checked 2026-10-03. SIREN published in the company's own legal notice, confirmed in the French business register
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 5 medical devices: ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (K260447, 2026), ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856, 2025), ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD (K232395, 2023) +2. 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)
• Website domain registered (record type: domain-registered) [our own observation, not an official record; status green] Shows how long this web address has been registered. That is the age of the domain, not of the company: a domain can change owners. checked 2026-08-26. Domain registry record
• financials-published (record type: financials-published) [official record; status green] Annual accounts filed for 2025: revenue €4.1B, profit €396.9M. 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 2025-12-31. INPI/BCE published accounts (data.economie.gouv.fr)
• 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. checked 2026-07-18. Yahoo Finance
• Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 563 public contracts on record, the latest awarded 2026-09-03. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. effective since 2026-09-03. DECP, French public-procurement register Tutaj wygrana niesie też cudzą kontrolę: w UE i EOG zamawiający musi wykluczyć wykonawcę skazanego za oszustwo, korupcję lub pranie pieniędzy oraz takiego, wobec którego prawomocnie stwierdzono zaległości podatkowe lub składkowe. Ta kontrola dotyczyła tamtego postępowania w dniu udzielenia zamówienia: nie pokazuje obecnej sytuacji firmy, a wygrana nie pokazuje, że umowa została wykonana. Directive 2014/24/EU, Article 57 (exclusion grounds)
• Registered business units on file (record type: registered-units) [official record; status green] 13 active business units of 20 on the register, 9 with a manufacturing activity code. The register lists how many sites the company runs. effective since 2026-10-01. INSEE Sirene (StockEtablissement)

Registered business units

13 active and 7 closed units in INSEE Sirene (StockEtablissement); 9 active units carry a manufacturing activity code (section C of the activity classification). The activity code is what the register records for each site, not a finding that goods are made there.

• 38390 LA BALME-LES-GROTTES: SIRET 67362039900018, active, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 1990-06-07, staff 500-999 (2024). INSEE Sirene (StockEtablissement)
• 376 CHEMIN DE L'ORME 69280 MARCY-L'ETOILE: SIRET 67362039900026, active, head office, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 1987-03-31, staff 1000-1999 (2024). INSEE Sirene (StockEtablissement)
• AVENUE DES BERGERIES 01150 SAINT-VULBAS: SIRET 67362039900083, active, manufacturing activity code 21.20Z (Fabrication de préparations pharmaceutiques), opened 1999-04-26, staff 100-199 (2024). INSEE Sirene (StockEtablissement)
• 2 RUE D'EPIAIS 95380 CHENNEVIERES-LES-LOUVRES: SIRET 67362039900117, active, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 2001-01-01. INSEE Sirene (StockEtablissement)
• ZONE ARTISANALE 69280 SAINTE-CONSORCE: SIRET 67362039900125, active, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 1998-01-01. INSEE Sirene (StockEtablissement)
• ROUTE DE DOL 35270 COMBOURG: SIRET 67362039900166, active, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 2013-12-31. INSEE Sirene (StockEtablissement)
• 37-39 37 RUE DE SURENE 75008 PARIS: SIRET 67362039900208, active, manufacturing activity code 21.20Z (Fabrication de préparations pharmaceutiques), opened 2020-01-27, staff 3-5 (2024). INSEE Sirene (StockEtablissement)
• 5 RUE DES AQUEDUCS 69290 CRAPONNE: SIRET 67362039900216, active, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 2021-03-03, staff 1000-1999 (2024). INSEE Sirene (StockEtablissement)
• 4 RUE DES COUTURES 35270 COMBOURG: SIRET 67362039900224, active, manufacturing activity code 21.20Z (Fabrication de préparations pharmaceutiques), opened 2022-10-11, staff 200-249 (2024). INSEE Sirene (StockEtablissement)
• ZONE POLYTEC 5 RUE DES BERGES 38000 GRENOBLE: SIRET 67362039900133, active, activity code 72.11Z (Recherche-développement en biotechnologie), opened 2005-09-01, staff 250-499 (2024). INSEE Sirene (StockEtablissement)
• PARC TECHNOLOGIQUE DELTA SUD 138 RUE LOUIS PASTEUR 09340 VERNIOLLE: SIRET 67362039900141, active, activity code 72.11Z (Recherche-développement en biotechnologie), opened 2013-01-01, staff 50-99 (2024). INSEE Sirene (StockEtablissement)
• CAMPUS DE KER LANN 1 RUE MARYSE BASTIE 35170 BRUZ: SIRET 67362039900158, active, activity code 72.19Z (Recherche-développement en autres sciences physiques et naturelles), opened 2013-12-31, staff 50-99 (2024). INSEE Sirene (StockEtablissement)
• 100 ALLEE LOUIS PASTEUR 69280 MARCY-L ETOILE: SIRET 67362039900182, active, activity code 82.19Z (Photocopie, préparation de documents et autres activités spécialisées de soutien de bureau), opened 2016-09-12, staff 500-999 (2024). INSEE Sirene (StockEtablissement)
• 5 RUE DES DOCTEURS MERIEUX 69290 CRAPONNE: SIRET 67362039900034, closed 2011-07-19, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 1986-06-13. INSEE Sirene (StockEtablissement)
• 33 RUE CENSIER 75005 PARIS: SIRET 67362039900042, closed 2020-01-27, manufacturing activity code 21.20Z (Fabrication de préparations pharmaceutiques), opened 1984-11-01. INSEE Sirene (StockEtablissement)
• 43 AVENUE DU 11 NOVEMBRE 1918 69160 TASSIN-LA-DEMI-LUNE: SIRET 67362039900091, closed 2019-09-27, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 1989-10-01. INSEE Sirene (StockEtablissement)
• 93 AVENUE DU 11 NOVEMBRE 1918 69160 TASSIN-LA-DEMI-LUNE: SIRET 67362039900109, closed 2008-04-30, manufacturing activity code 20.59Z (Fabrication d'autres produits chimiques n.c.a.), opened 1994-09-01. INSEE Sirene (StockEtablissement)
• 070-086 70 AVENUE DE LA REPUBLIQUE 92320 CHATILLON: SIRET 67362039900075, closed 1997-12-25, trade activity code 51.4N, opened 1997-10-01. INSEE Sirene (StockEtablissement)
• 3 ALLEE DE LA SEINE 94200 IVRY-SUR-SEINE: SIRET 67362039900174, closed 2017-03-14, activity code 72.11Z (Recherche-développement en biotechnologie), opened 2013-12-31. INSEE Sirene (StockEtablissement)
• 1 RUE LENINE 94200 IVRY-SUR-SEINE: SIRET 67362039900190, closed 2020-10-02, activity code 82.11Z (Services administratifs combinés de bureau), opened 2017-03-14. INSEE Sirene (StockEtablissement)

Claimed certifications, not confirmed by us

• ISO 13485, Medical Devices Quality IAF CertSearch
• CE Marking EU NANDO (notified bodies)

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

Before a first order, ask for the ISO 13485, Medical Devices Quality certificate number, its holder and the products it covers.

• Sanctions and watchlists (OpenSanctions)