Establishment Labs Holdings Inc.
Fabricante costarricense de dispositivos médicos especializado en estética mamaria.
Establishment Labs fabrica los implantes mamarios Motiva y tecnologías relacionadas para dispositivos médicos en Costa Rica. Fundada en 2004, la empresa abastece a cirujanos plásticos, clínicas y distribuidores en mercados regulados de dispositivos médicos en todo el mundo.
- Type
- brand seeking distribution
- Location
- Alajuela, Costa Rica
- Founded
- 2004
- Website
- establishmentlabs.com
- Categories
- Suministros médicos y sanitarios
- Markets
- Costa Rica, Estados Unidos, Brasil, Alemania
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)