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Establishment Labs

Costa Rica Last updated 21 Oct 2026

Devices
1,359
Registries
EUDAMED
FDA recalls
0

Catalogue1,359

Page 18 of 28

Showing 851-900 of 1,359

EUDAMED certificates4

EUDAMED certificates (4)

Notified body 2797 4 certificates

  • MDR 798371 Supplemented

    Technical documentation EU MDR

    Issued
    12 Jun 2026
    Expires
    1 Jan 2030
    Reason
    Change approved
  • MDR 768275 Supplemented

    Technical documentation EU MDR

    Issued
    12 Jun 2026
    Expires
    5 Jan 2028
    Reason
    Change approved
  • MDR 768277 Supplemented

    Technical documentation EU MDR

    Issued
    12 Jun 2026
    Expires
    5 Jan 2028
    Reason
    Change approved
  • MDR 745219 Supplemented

    Technical documentation EU MDR

    Issued
    12 Jun 2026
    Expires
    22 May 2027
    Reason
    Change approved

Authorised representatives

Notified bodies

  • Notified body 2797

About

A global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology.

From the manufacturer's own website. Source

What Establishment Labs makes

Establishment Labs manufactures a range of vaginal health devices, including injectable solutions, inflatable balloons, and various implantable products under the Motiva brand. These products are designed for medical applications in pelvic floor and vaginal tissue treatment, such as tissue augmentation and structural support.

The company’s devices are classified under EU regulations as Class I, Class IIa, and Class III, with listings maintained in the EUDAMED database. The manufacturer is based in Costa Rica and adheres to relevant regulatory frameworks for medical devices in the European market.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Address
Coyol Free Zone & Business Park Building 4th street, building B15 Alajuela Costa Rica, Alajuela, Costa Rica
Phone
+506 2434-2400
PRRC contact
Alberto Quesada Rivera
EUDAMED SRN
CR-MF-000008155