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Motiva Implants

by Establishment Labs EUDAMED

Active European Union

Ref DSM-165ZModel DSM-100Z

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  • Withdrawn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

Device Name
Motiva Ergonomix2 Diamond, Sterile Silicone Breast Implants - Mini with Zen 100cc - S
Model / Reference
DSM-100Z, DSM-165Z
Primary DI / UDI-DI
07445161009319
Basic UDI-DI
7445161Ergo2ZenBQ
Market of Registration
Belgium

Manufacturer details

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

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