<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08717694024176</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:06.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024183</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:06.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024190</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX255</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:06.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024206</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX285</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024213</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024220</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX340</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024237</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024244</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024251</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX425</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024268</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX455</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024275</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX470</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024282</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX515</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024299</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX570</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024305</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024312</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX680</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024329</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX725</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717694024336</udiDi>
    <basicUdiDi>8717694a00006SD</basicUdiDi>
    <tradeName>MENTOR Round High Profile Xtra Sterile Resterilizable Gel Breast Implant Sizer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MENTOR MEDICAL SYSTEMS B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000011681</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSZTHPX765</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:35:05.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161006417</udiDi>
    <basicUdiDi>7445161InflataballoonPA</basicUdiDi>
    <tradeName>Motiva Inflatable Balloon</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MIB-0100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:20:17.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161006431</udiDi>
    <basicUdiDi>7445161injector7R</basicUdiDi>
    <tradeName>Motiva Injector</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>INJM-23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:20:17.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>07445161009494</udiDi>
    <basicUdiDi>7445161InflataballoonPA</basicUdiDi>
    <tradeName>Motiva Inflatable Balloon</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0680</emdnCode>
    <emdnDescription>BREAST IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIB-0080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:20:17.546Z</lastUpdated>
  </row>
</eudamedExport>