Fujifilm

What is established and what is not

No researcher review has been written for this company yet. 6 official records from 6 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

• 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 2026-08-08. Mail server of the company domain
• 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 2026-08-08. Domain registry record
• 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-08. 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 2026-08-08. 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. Screened by name only: no legal entity is established for this record, so this is not a clearance. checked 2026-08-08. OpenSanctions
• Registry ID checks out with the state register (record type: registry-link-unconfirmed) [official record; status amber] A register record with this number exists, but its link to this company is not established: the registered name or address does not confirm it. checked 2026-09-22. gBizINFO (Ministry of Economy, Trade and Industry), government-held corporate data
• Workplace on the state insurance register (record type: registry-link-unconfirmed) [official record; status amber] A register record with this number exists, but its link to this company is not established: the registered name or address does not confirm it. checked 2026-09-28. gBizINFO (Ministry of Economy, Trade and Industry), establishment records from the social insurance system
• EAEU product declaration on record, company's role not established (record type: eaeu-product-declaration-party; this record does not by itself establish manufacturing) [official record; status green] An official EAEU register holds a declaration for specific goods that names this company; the record we hold does not say in which role (manufacturer, applicant or representative). It shows those products may be sold on the EAEU market, not a general quality mark. Paste the document number into the register search to see the record. checked 2026-08-16. EAEU unified register of certificates and declarations
• product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 1 medical devices: Synapse 3D, Synapse 3D Base Tools v6.1 (K203103, 2021). 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)
• 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. Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados

Claimed certifications, not confirmed by us

• ISO 9001, Quality Management IAF CertSearch
• ISO 13485, Medical Devices Quality IAF CertSearch

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)

Goods family established: 医療およびヘルスケア用品 (official record of a specific product). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category 家電: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.

Check independently

Before a first order, ask for the ISO 9001, Quality Management certificate number, its holder and the products it covers.

• Sanctions and watchlists (OpenSanctions)