Establishment Labs Holdings Inc.
Costa Ricaanse fabrikant van medische hulpmiddelen richtte zich op borstesthetiek.
Establishment Labs produceert Motiva-borstimplantaten en aanverwante technologieën voor medische apparatuur uit Costa Rica. Het bedrijf, opgericht in 2004, levert aan plastisch chirurgen, klinieken en distributeurs in gereguleerde markten voor medische hulpmiddelen over de hele wereld.
- 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
- Medische en gezondheidszorgbenodigdheden
- Markets
- Costa Rica, Verenigde Staten, Brazilië, Duitsland
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)