Eighteeth Medical (Changzhou) Co., Ltd.
Endodontic motor and apex locator OEM from Jiangsu for dental wholesale.
Eighteeth Medical manufactures endodontic motors, apex locators, rotary file systems and oral irrigators in Changzhou, Jiangsu Province. The company exports to more than 80 countries through dental distribution networks and holds CE and ISO 13485 certifications. Its portable endo motors are popular OEM candidates for European dental brands.
- Type
- Manufacturer
- Location
- Changzhou, China
- Founded
- 2007
- Website
- eighteeth.com
- Categories
- Medical & Healthcare Supplies, Dental Supplies & Equipment
- Markets
- China, Germany, France, South Korea, Brazil
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
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- lei-lapsed (amber), checked 2026-08-08 GLEIF
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
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)