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Motiva Implants

by Establishment Labs EUDAMED

Active European Union

Ref E2OM-115Model Motiva Implants Ergonomix2 Oval SmoothSilk

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 768275 Date12 Jun 2026IssuedStatusActive expires 5 Jan 2028

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 768275 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    12 Jun 2026
    Expires
    5 Jan 2028
    Reason
    Change approved

Specification

EUDAMED

Model / Reference
Motiva Implants Ergonomix2 Oval SmoothSilk, E2OM-115
Primary DI / UDI-DI
07445161022943
Basic UDI-DI
7445161Ergo2OvalWM
EMDN Code
P0601010202,X020102
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

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

Other devices from Establishment Labs

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Properties

Show properties
  • 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