<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>76126750012636</udiDi>
    <basicUdiDi>B-76126750012636</basicUdiDi>
    <tradeName>76126750012636</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPTRON AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041313</manufacturerSrn>
    <authorisedRepresentativeName>MDR Regulator Sp. z o. o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000002485</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAG-990</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:42:37.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>76126750024752</udiDi>
    <basicUdiDi>B-76126750024752</basicUdiDi>
    <tradeName>BIOPTRON B2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPTRON AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041313</manufacturerSrn>
    <authorisedRepresentativeName>MDR Regulator Sp. z o. o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000002485</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAG-880</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:42:21.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>76126750028880</udiDi>
    <basicUdiDi>B-76126750028880</basicUdiDi>
    <tradeName>BIOPTRON MedAll</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPTRON AG</manufacturerName>
    <manufacturerSrn>CH-MF-000041313</manufacturerSrn>
    <authorisedRepresentativeName>MDR Regulator Sp. z o. o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000002485</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAG-960</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:42:11.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800048600635</udiDi>
    <basicUdiDi>B-08800048600635</basicUdiDi>
    <tradeName>Juverax Shape with lidocaine</tradeName>
    <deviceName>Juverax Shape with lidocaine</deviceName>
    <manufacturerName>RFBio Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000036562</manufacturerSrn>
    <authorisedRepresentativeName>MDR Regulator Sp. z o. o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000002485</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:13:31.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800048600208</udiDi>
    <basicUdiDi>B-08800048600208</basicUdiDi>
    <tradeName>dermaren SUB-Q with lidocaine</tradeName>
    <deviceName>dermaren SUB-Q with lidocaine</deviceName>
    <manufacturerName>RFBio Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000036562</manufacturerSrn>
    <authorisedRepresentativeName>MDR Regulator Sp. z o. o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000002485</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-BR0003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:13:30.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800048600154</udiDi>
    <basicUdiDi>B-08800048600154</basicUdiDi>
    <tradeName>SARDENYA Shape with lidocaine</tradeName>
    <deviceName>SARDENYA Shape with lidocaine</deviceName>
    <manufacturerName>RFBio Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000036562</manufacturerSrn>
    <authorisedRepresentativeName>MDR Regulator Sp. z o. o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000002485</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-BR0002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:13:28.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800048600086</udiDi>
    <basicUdiDi>B-08800048600086</basicUdiDi>
    <tradeName>YOUTHFILL Shape with lidocaine</tradeName>
    <deviceName>YOUTHFILL Shape with lidocaine</deviceName>
    <manufacturerName>RFBio Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000036562</manufacturerSrn>
    <authorisedRepresentativeName>MDR Regulator Sp. z o. o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000002485</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900402</emdnCode>
    <emdnDescription>RESORBABLE FILLING AND RECONSTRUCTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R-BR0001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:13:22.804Z</lastUpdated>
  </row>
</eudamedExport>