HORIBA
Analytical instruments, measuring systems and diagnostic devices.
HORIBA manufactures analytical instruments, measuring systems and diagnostic devices from its Kyoto operations. The company serves domestic buyers, OEM customers, retailers or export channels across its listed primary markets.
- Type
- Manufacturer
- Location
- Kyoto, Japan
- Founded
- 1945
- Website
- horiba.com
- Categories
- Industrial Machinery, Medical & Healthcare Supplies
- Markets
- Japan, United States, Germany, China
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- domain-registered (green), checked 2026-08-08 Domain registry record
- web-presence-since (green), checked 2026-08-08 Internet Archive (Wayback)
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- fda-contract-manufacturer (green), checked 2026-08-08 FDA
- fda-registered (green), checked 2026-08-08 FDA
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- certificate-page-on-site (amber), checked 2026-08-11 Company's own certification page
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality 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)
- Machinery sold in the EU needs CE marking with a declaration of conformity under the EU machinery rules. European Commission