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<eudamedExport entity="devices">
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    <udiDi>03664685005520</udiDi>
    <basicUdiDi>B-03664685005520</basicUdiDi>
    <tradeName>CEREFORM®</tradeName>
    <deviceName>CEREFORM® SILICONE GEL-FILLED BREAST IMPLANTS</deviceName>
    <manufacturerName>Euromi Biosciences</manufacturerName>
    <manufacturerSrn>BE-MF-000020089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVHS160</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:42:48.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161018106</udiDi>
    <basicUdiDi>7445161ErgoVelvetZenPE</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERVM-105Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:27.992Z</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>07445161011060</udiDi>
    <basicUdiDi>7445161ErgoVelvetM5</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ERVM-105</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:07.942Z</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>07445161007261</udiDi>
    <basicUdiDi>7445161VelvetPlusZenEJ</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-105+Z</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:38:00.742Z</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>07445161004802</udiDi>
    <basicUdiDi>7445161VelvetPlus62</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-105+</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:37:59.152Z</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>00081317001959</udiDi>
    <basicUdiDi>0081317a000053Z</basicUdiDi>
    <tradeName>MENTOR Smooth Round SPECTRUM
Saline Breast Implant</tradeName>
    <deviceName>MENTOR SPECTRUM Breast Implants</deviceName>
    <manufacturerName>MENTOR</manufacturerName>
    <manufacturerSrn>US-PR-000013792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010101</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, SALINE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>350-1410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:12:23.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>00081317001171</udiDi>
    <basicUdiDi>0081317a000043X</basicUdiDi>
    <tradeName>MENTOR Smooth Round Moderate Profile
Saline Breast Implant</tradeName>
    <deviceName>MENTOR Saline-Filled Breast Implants</deviceName>
    <manufacturerName>MENTOR</manufacturerName>
    <manufacturerSrn>US-PR-000013792</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0601010101</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, SALINE, WITH SMOOTH SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>350-1610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:12:22.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161004826</udiDi>
    <basicUdiDi>7445161VelvetPlus62</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-140+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:33.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161004833</udiDi>
    <basicUdiDi>7445161VelvetPlus62</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-150+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:33.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161004840</udiDi>
    <basicUdiDi>7445161VelvetPlus62</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-160+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:33.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161004857</udiDi>
    <basicUdiDi>7445161VelvetPlus62</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-170+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:33.316Z</lastUpdated>
  </row>
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    <udiDi>07445161004864</udiDi>
    <basicUdiDi>7445161VelvetPlus62</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-185+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:33.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161004871</udiDi>
    <basicUdiDi>7445161VelvetPlus62</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>P0601010202</emdnCode>
    <emdnDescription>BREAST IMPLANTS, ROUND, MADE OF SILICONE, WITH TEXTURED SURFACE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RVM-205+</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:09:33.277Z</lastUpdated>
  </row>
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