Fujirebio 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. 14 official records from 9 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)
• 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
• 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
• 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)
• Legally registered and still active (record type: registry-active-global) [official record; status green] Indicates the company is not dissolved or winding down. checked 2026-10-15. Crossroads Bank for Enterprises (KBO/BCE), full open-data file
• registry-activity (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. checked 2026-10-15. Crossroads Bank for Enterprises (KBO/BCE), full open-data file
• 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)
• Named directors on file (record type: directors-on-file) [official record; status green] 4 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: Technologiepark-Zwijnaarde 6, 9052 Gent. 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 1985-07-18. 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
• 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)
• manufacturing-practice-certified (record type: manufacturing-practice-certified) [official record; status green] A regulator of health products inspected this site and certified how it manufactures the product class named, for example medical devices or cosmetics. It is about manufacturing practice at the site, not a medicines licence. checked 2026-10-03. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
• Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-03. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
• 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

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

• 4 more officer(s), not named in the record: Officer in the register. Crossroads Bank for Enterprises (KBO/BCE) public search, Belgium
• 9615837: Site named in the record, registry number 9615837. US FDA device establishment registration (openFDA)
• Technologiepark 6, 9052, Zwijnaarde: Holds the site's permit, registry number FAGG2015022601. TRACES NT, European Commission register of approved establishments (DG SANTE)
• TECHNOLOGIEPARK, 6, ZWIJNAARDE, GHENT - 9052: Manufactures at the site. ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)

Import rules for these goods

Product-specific import rules not established for the catalog category Tıbbi ve Sağlık Malzemeleri: 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)