Establishment Labs
Active in EUDAMEDCosta Ricafrom SRN EUDAMED SRN CR-MF-000008155
- Devices
- 1,359
- Registrations
- EUDAMED
Catalogue
Motiva Implants Ref E2OM-165Z
Motiva Implants Ref E2SF-380
Motiva Implants Ref ERSD-525Z
Motiva Implants Ref ERVF-700Z
Motiva Implants Ref DSC-370Z
Motiva Implants Ref E2SD-545Z
Motiva Implants Ref E2SD-210Z
Motiva Implants Ref DSD-255T
Motiva Implants Ref RVF-315+
Motiva Implants Ref E2SM-110
Motiva Implants Ref E2OF-330T
Motiva Implants Ref RVF-775+Z
Motiva Implants Ref E2SF-155Z
Motiva Implants Ref RVD-525+
Motiva Implants Ref E2OM-300
Motiva Implants Ref E2SC-320Z
Motiva Implants Ref RVD-340+
Motiva Implants Ref E2SF-380T
Motiva Implants Ref E2SF-535T
Motiva Implants Ref ERSF-255Z
Motiva Implants Ref RSD-135+Z
Motiva Implants Ref E2OD-160
Motiva Implants Ref E2OD-635
Motiva Implants Ref DSM-335Z
Motiva Implants Ref ERVM-185
Motiva Implants Ref E2OC-475T
Motiva Implants Ref E2SD-605
Motiva Implants Ref DSD-270
Motiva Implants Ref RSD-380+Z
Motiva Implants Ref ERSD-625
Motiva Implants Ref E2SF-670Z
Motiva Implants Ref ERSD-475Z
Motiva Implants Ref DSC-355Z
Motiva Implants Ref RVC-440+Z
Motiva Implants Ref ERVC-590Z
Motiva Implants Ref ERVM-400
Motiva Implants Ref E2OF-620
Motiva Implants Ref RSM-160+
Motiva Implants Ref RVF-175+Z
Motiva Implants Ref RVF-335+
Motiva Implants Ref E2SC-860Z
Motiva Implants Ref RVF-625+
Motiva Implants Ref E2SC-270Z
Motiva Implants Ref DSD-140T
Motiva Implants Ref E2SC-190
Motiva Implants Ref ERVF-295
Motiva Implants Ref ERSC-260
Motiva Implants Ref ERVF-175
Motiva Implants Ref E2OD-425Z
Motiva Implants Ref RVD-475+
Showing 601-650 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
- Website
- establishmentlabs.com
- [email protected]
- Phone
- +506 2434-2400
- PRRC contact
- Alberto Quesada Rivera
EUDAMED certificates
4 certificates4 valid, 0 expiredMDR 4next expiry 22 May 2027
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
A global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology.
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.