Establishment Labs Holdings Inc.
Fabricante de dispositivos médicos da Costa Rica com foco na estética das mamas.
A establishment Labs fabrica implantes mamários Motiva e tecnologias de dispositivos médicos relacionados na Costa Rica. Fundada em 2004, a empresa fornece cirurgiões plásticos, clínicas e distribuidores em mercados regulamentados de dispositivos médicos em todo o mundo.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Alajuela, Costa Rica
- Founded
- 2004
- Website
- establishmentlabs.com
- Categories
- Suprimentos médicos e de saúde
- Markets
- Costa Rica, Estados Unidos, Brasil, Alemanha
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- sanctions-clear (green), checked 2026-08-08 - screened by name only: no legal entity is established for this record, so this is not a clearance OpenSanctions
- debarment-clear (green), checked 2026-08-08 - screened by name only: no legal entity is established for this record, so this is not a clearance 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)