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Motiva Implants

by Establishment Labs Costa Rica EUDAMED

Ref ERSC-1050Model Motiva Implants Ergonomix Round SmoothSilk/SilkSurface

EMDN P0601010201,X020102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 745219 Date12 Jun 2026IssuedStatusWithdrawn No longer placed on the EU market expires 22 May 2027

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 745219 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    12 Jun 2026
    Expires
    22 May 2027
    Reason
    Change approved

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Motiva Implants Ergonomix Round SmoothSilk/SilkSurface, ERSC-1050
Primary DI / UDI-DI
07445161011053
Basic UDI-DI
7445161ErgoroundR5
EMDN Code
P0601010201,X020102
Device Class
Class III

Manufacturer details

EUDAMED SRN
CR-MF-000008155
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Establishment Labs

See all devices from Establishment Labs →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED f2757b06-8b9a-42f3-b4de-a333e655ae42 61 fields · synced 22 Oct 2026