Establishment Labs Holdings Inc.
Costa Rican medical-device manufacturer focused on breast aesthetics.
Establishment Labs manufactures Motiva breast implants and related medical-device technologies from Costa Rica. Founded in 2004, the company supplies plastic surgeons, clinics, and distributors in regulated medical-device markets worldwide.
- Type
- Manufacturer
- Location
- Alajuela, Costa Rica
- Founded
- 2004
- Website
- establishmentlabs.com
- Categories
- Medical & Healthcare Supplies
- Markets
- Costa Rica, United States, Brazil, Germany
Verified facts
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- 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
- registered-manufacturer (green), checked 2026-08-22 Agencia Estatal de Medicamentos y Tecnologias en Salud (AGEMED, Bolivia), listado oficial de registros sanitarios aprobados
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)