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Establishment Labs

Manufacturer of medical devices registered in the European database in Alajuela, Costa Rica.

Registration number (SRN)CR-MF-000008155
Short nameESTA
RoleManufacturer
StatusActive
CountryCosta Rica
City20113 Alajuela
AddressCoyol Free Zone & Business Park Building 4th street, building B15 Alajuela Costa Rica, 20113 Alajuela
Registered on2021-06-24

United States market access

FDA establishment register Similar name in the FDA register — unverified
Matched entryESTABLISHMENT LABS S.A. (CR) · FDA 3012883202

⚠️ A similar name exists. We do not assert it is the same company — a name alone is not proof. This one needs a human check.

Notified body certificates

CertificateStatusExpiryTypeBody
MDR 798371supplemented2030-01-01Technical documentationNB 2797
MDR 768275supplemented2028-01-05Technical documentationNB 2797
MDR 745219supplemented2027-05-22Technical documentationNB 2797

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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