TOKAI OPTICAL CO., LTD.
Japanese manufacturer of high-tech ophthalmic lenses and specialty thin lenses in Okazaki, with e…
Japanese manufacturer of high-tech ophthalmic lenses and specialty thin lenses in Okazaki, with export sales to Germany, the US and Thailand.
- Type
- Manufacturer
- Location
- Okazaki, Japan
- Founded
- 1952
- Website
- tokaiopt.com
- Categories
- Eyewear & Sunglasses, Medical & Healthcare Supplies
- Markets
- Japan, Germany, United States, Thailand, China
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- sanctions-clear (green), checked 2026-08-09 OpenSanctions
- fda-registered (green), checked 2026-08-09 FDA
- market-access-us (green), checked 2026-08-23 FDA device establishment registration (openFDA, U.S. Food and Drug Administration)
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- 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)
- Sunglasses and protective eyewear are personal protective equipment in the EU: CE marking under Regulation (EU) 2016/425 is required. European Commission (PPE)