Establishment Labs Holdings Inc.
乳房の美しさに重点を置いたコスタリカの医療機器メーカー。
establishment Labs は、Motiva 乳房インプラントと関連する医療機器技術をコスタリカで製造しています。 2004 年に設立された同社は、世界中の規制された医療機器市場の形成外科医、診療所、販売代理店に製品を供給しています。
- 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
- 医療およびヘルスケア用品
- Markets
- コスタリカ, アメリカ合衆国, ブラジル, ドイツ
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)