Establishment Labs Holdings Inc.
Fabricant costaricien de dispositifs médicaux spécialisé dans l'esthétique mammaire.
Establishment Labs fabrique les implants mammaires Motiva et les technologies de dispositifs médicaux connexes au Costa Rica. Fondée en 2004, l'entreprise fournit des chirurgiens plasticiens, des cliniques et des distributeurs sur les marchés réglementés des dispositifs médicaux du monde entier.
- Type
- brand seeking distribution
- Location
- Alajuela, Costa Rica
- Founded
- 2004
- Website
- establishmentlabs.com
- Categories
- Fournitures médicales et de santé
- Markets
- Costa Rica, États-Unis, Brésil, Allemagne
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)