Hugel Inc.
B2B manufacturer of botulinum toxin and aesthetic HA fillers
Hugel manufactures botulinum toxin (Botulax) and hyaluronic acid dermal fillers for medical aesthetic distributors. Its products are licensed in over 60 countries and produced in a dedicated GMP-certified biologics facility.
- Type
- Manufacturer
- Location
- Seoul, South Korea
- Founded
- 2001
- Website
- hugel-aesthetics.com
- Categories
- Personal Care, Medical & Healthcare Supplies
- Markets
- South Korea, United States, United Arab Emirates, Australia, Germany
Verified facts
- domain-registered (green), checked 2026-08-07 Domain registry record
- gmp-certified (green), checked 2026-08-21 ANVISA (Brazilian Health Regulatory Agency), public register of Good Manufacturing Practice certificates (CBPF)
- places-goods-on-market (green), checked 2026-08-16 Registre national des producteurs (ADEME/SYDEREP), France
Import rules for these goods
- Cosmetic products must be notified in the EU Cosmetic Products Notification Portal (CPNP) before being placed on the EU market. European Commission (CPNP)
- For the US market, MoCRA requires cosmetic facility registration and product listing with the FDA. US FDA (MoCRA)
- 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)