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Establishment Labs

Active in EUDAMED

Costa Ricafrom SRN EUDAMED SRN CR-MF-000008155

Devices
1,359
Registrations
EUDAMED

Catalogue1,359

Newest first, page 15 of 28

Showing 701-750 of 1,359

Company details

EUDAMED SRN
CR-MF-000008155
EUDAMED status
Active
EUDAMED registered name
Establishment Labs
EUDAMED abbreviated name
ESTA
Registered address
Coyol Free Zone & Business Park Building 4th street, building B15 Alajuela Costa Rica, 20113, Alajuela, Costa Rica
Phone
+506 2434-2400
PRRC contact
Alberto Quesada Rivera(public in EUDAMED)

EUDAMED certificates4

4 certificates4 valid, 0 expiredMDR 4next expiry 22 May 2027

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

From the company website

Read 18 Sep 2026

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.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.