Terumo BCT Europe N.V.

Listed in a source registry

US FDA device registration and listing (open.fda.gov)

What is established and what is not

No researcher review has been written for this company yet. 13 official records from 8 official sources are on file. 2 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

• Site address listed in a government regulator's register (record type: facility-registered; this record does not by itself establish manufacturing) [official record; status green] Shows the regulator records a site of this company at a named address. A registration is not an observation of current production. effective since 2026-08-17. US FDA device establishment registration (openFDA)
• 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 2026-08-15. 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 2026-08-15. OpenSanctions
• 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 2026-08-15. FDA
• Registered with the U.S. FDA as a Contract Manufacturer (record type: fda-contract-manufacturer) [official record; status green] Registered as making goods for other brands. checked 2026-08-15. FDA
• 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)
• Registered with the state to export across borders (record type: export-registered) [official record; status green] Required to move goods across borders. checked 2026-08-07. US FDA device establishment registration (openFDA)
• Workforce size in the company register (record type: workforce-on-record) [official record; status green] Tells you whether the supplier can realistically take on your volume. checked 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
• 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)
• 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 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
• Street address on file in the state register (record type: registered-address) [official record; status green] Registered address: Ikaroslaan 41, 1930 Zaventem. The address the company itself gave the register, so post and inspectors reach it there. checked 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
• On the company register (record type: registered-since) [official record; status green] On the company register since 1973-05-11. Shows how long the company has been on the state register, which is hard to fake and easy to check. checked 2026-10-03. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
• Takes part in public tenders (record type: public-contract-awarded) [official record; status green] 48 public contracts on record, the latest awarded 2026-10-02. A public buyer selected this supplier through an official tender. Open the source for the contracts themselves. checked 2026-10-02. TED (Tenders Electronic Daily), EU public procurement award notices Hier draagt de gunning ook een controle van een ander: in de EU en de EER moet een publieke inkoper inschrijvers uitsluiten die zijn veroordeeld voor fraude, corruptie of witwassen, en degenen bij wie een definitief besluit belasting of premieschulden heeft vastgesteld. Die controle gold voor die aanbesteding op de datum van gunning: ze toont niet de huidige situatie van het bedrijf, en een gunning toont niet dat het contract is uitgevoerd. Directive 2014/24/EU, Article 57 (exclusion grounds)
• 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 2026-09-10. GLEIF Global LEI record
• Registered business units on file (record type: registered-units) [official record; status green] 2 active business units on the register, 2 with a manufacturing activity code. The register lists how many sites the company runs. effective since 2026-10-02. Crossroads Bank for Enterprises (KBO/BCE), establishment units

Registered business units

2 active units in Crossroads Bank for Enterprises (KBO/BCE), establishment units (its open data lists active units only, so closed units are not counted here); 2 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.

• Ikaroslaan 41, 1930 Zaventem: Establishment unit 2.037.761.944, trade name Terumo BCT Europe, active, manufacturing activity code 26.60001 (Fabrication d'appareils électriques pour la médecine, l'art dentaire et l'art vétérinaire), manufacturing activity code 32.500 (Fabrication d'instruments et de fournitures à usage médical et dentaire), manufacturing activity code 32.50003 (Fabrication de mobilier pour la médecine, la chirurgie, l'art dentaire ou l'art vétérinaire: tables d'opération, lits à mécanismes pour usages cliniques, fauteuils de dentistes), manufacturing activity code 33.190 (Réparation et entretien d'autres équipements), activity code 73.20002 (Analyses statistiques des résultats de ces études), activity code 74.999 (Autres activités des professions libérales et autres activités scientifiques et techniques, nca), opened 1973-09-01. Crossroads Bank for Enterprises (KBO/BCE), establishment units
• Romeinse straat 8, 3001 Leuven: Establishment unit 2.230.421.265, active, manufacturing activity code 26.60001 (Fabrication d'appareils électriques pour la médecine, l'art dentaire et l'art vétérinaire), opened 2013-04-01. Crossroads Bank for Enterprises (KBO/BCE), establishment units

Import rules for these goods

Product-specific import rules not established for the catalog category Medische en gezondheidszorgbenodigdheden: neither the company's own description nor an official activity code shows that its own goods are of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.

Check independently

• Sanctions and watchlists (OpenSanctions)