<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07445161009296</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName>Motiva Ergonomix2 Diamond , Sterile Silicone Breast Implants - Mini with Zen 100cc - S</deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSM-125Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:36:09.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161008077</udiDi>
    <basicUdiDi>7445161ErgoroundZen8Y</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName>Breast Implant Round - Mini with Qid Ergonomix 105 cc - S</deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERSM-125Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:36:08.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161006479</udiDi>
    <basicUdiDi>7445161SilkPlusZen8Z</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSM-125+Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:36:03.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161001610</udiDi>
    <basicUdiDi>7445161SilkPlusS4</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSM-125+</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:35:54.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161017703</udiDi>
    <basicUdiDi>7445161Ergo2DiamondDH</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSM-100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:27.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161015402</udiDi>
    <basicUdiDi>7445161Ergo2AX</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName>Silicone Breast Motiva Implants Ergonomix2 SmoothSilk</deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E2SM-95</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:11.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161010261</udiDi>
    <basicUdiDi>7445161ErgoroundR5</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERSM-105</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:07.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009289</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName>Motiva Ergonomix2 Diamond , Sterile Silicone Breast Implants - Mini with Zen 100cc - S</deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSM-100Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:06.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161008060</udiDi>
    <basicUdiDi>7445161ErgoroundZen8Y</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName>Breast Implant Round - Mini with Qid Ergonomix 105 cc - S</deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERSM-105Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:05.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161006462</udiDi>
    <basicUdiDi>7445161SilkPlusZen8Z</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSM-105+Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:59.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161001603</udiDi>
    <basicUdiDi>7445161SilkPlusS4</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSM-105+</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:58.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009302</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSM-140Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:11.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009319</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSM-165Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:11.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009326</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSM-190Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:11.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009333</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD-120Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:11.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009340</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD-140Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:11.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009357</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD-170Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:11.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009364</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD-195Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:10.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009371</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD-220Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:10.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009388</udiDi>
    <basicUdiDi>7445161Ergo2ZenBQ</basicUdiDi>
    <tradeName>Motiva Implants</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Establishment Labs</manufacturerName>
    <manufacturerSrn>CR-MF-000008155</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010201</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSF-135Z</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:10.922Z</lastUpdated>
  </row>
</eudamedExport>