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Motiva Implants

by Establishment Labs Costa Rica EUDAMED

Ref SZM-245ZModel Motiva Implants Round Sizers with Zen

EMDN P0699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7445161RoundsizersZenDE Basic UDI-DIDate5 Nov 2025RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
Motiva Implants Round Sizers with Zen, SZM-245Z
Primary DI / UDI-DI
07445161019301
Basic UDI-DI
7445161RoundsizersZenDE
EMDN Code
P0699 Breast implants - other
Device Class
Class IIa

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
Other properties (12)
  • Implantable: No
  • 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 6d1ccc7b-53d5-4383-9dfa-c75e1ec12e9f 61 fields · synced 23 Oct 2026