YASUI CO., LTD.
安井株式会社
Providing high quality, reliable and safe products (ISO13485 certified), 6 divisions: Medical/Printing/Foaming/Injection/Trading/Development. Introducing koplight, a transparent high-performance resin hook with LED lighting that brightens the surgical field. Sales of CACTUS high-performance oil adsorption mat (CACTUS).
- Type
- brand seeking distribution
- Location
- Higashiusuki-gun Miyazaki, Japan
- Website
- https://yasui-kk.co.jp
- Categories
- 의료 및 건강 관리 용품
Listed in a source registry
Verified facts
- lei-lapsed (amber), checked 2026-08-14 GLEIF
- fda-contract-manufacturer (green), checked 2026-08-14 FDA
- corporate-mail-on-domain (green), checked 2026-08-14 Mail server of the company domain
- debarment-clear (green), checked 2026-08-14 OpenSanctions
- fda-registered (green), checked 2026-08-14 FDA
- sanctions-clear (green), checked 2026-08-14 OpenSanctions
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
Claimed certifications
- FDA Registered FDA Establishment Registration
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)