Skip to content

Motiva Implants

by Establishment Labs EUDAMED

Active European Union

Ref ERSM-220ZModel ERSM-105Z

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 745219 Date12 Jun 2026IssuedStatusActive expires 22 May 2027

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  • Withdrawn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 745219 Supplemented

    Technical documentation EU MDR

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

Specification

EUDAMED

Device Name
Breast Implant Round - Mini with Qid Ergonomix 105 cc - S
Model / Reference
ERSM-105Z, ERSM-220Z
Primary DI / UDI-DI
07445161008145
Basic UDI-DI
7445161ErgoroundZen8Y
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

See all devices from Establishment Labs →