YASUI CO., LTD.

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. 3 official records from 2 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

• Legal entity ID lapsed (record type: lei-lapsed-by-name) [our own observation, not an official record; status amber] A search of the GLEIF register by company name found an identifier under this name that was not renewed. The match is by name only, so it may belong to another legal entity. This does not mean the company closed. checked 2026-08-14. GLEIF
• 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 2026-08-14. FDA
• 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 2026-08-14. Mail server of the company domain
• 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 2026-08-14. 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 2026-08-14. FDA
• 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 2026-08-14. OpenSanctions
• Site address listed in a government regulator's register (record type: facility-registered) [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. checked 2026-08-07. US FDA device establishment registration (openFDA)

Relationships

1 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.

Candidates, not confirmed

• yasui-kk.co.jp: Website of this business. Source record

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)