Shofu Inc.
Shofu's philosophy is to "contribute to the advancement of dental care and people's health," and we provide high-quality products through an integrated system that covers everything from research and development to manufacturing and quality assurance for dental materials, equipment, and self-care products.
Shofu's philosophy is to "contribute to the advancement of dental care and people's health," and we provide high-quality products through an integrated system that covers everything from research and development to manufacturing and quality assurance for dental materials, equipment, and self-care products.
- Type
- Manufacturer
- Location
- Kyoto, Japan
- Website
- https://www.shofu.co.jp/
- Categories
- Dental Supplies & Equipment
- Markets
- Japan
Verified facts
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
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)