<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719880129249</udiDi>
    <basicUdiDi>471988012S04LG</basicUdiDi>
    <tradeName>04719880129249</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taiwan Advanced Nanotech Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000019040</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Maelstrom 8 Autostage (220V)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:57:26.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719880129195</udiDi>
    <basicUdiDi>471988012M481073</basicUdiDi>
    <tradeName>04719880129195</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taiwan Advanced Nanotech Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000019040</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Maelstrom 4810 (220V)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:57:25.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719880128907</udiDi>
    <basicUdiDi>471988012M24105Z</basicUdiDi>
    <tradeName>04719880128907</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taiwan Advanced Nanotech Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000019040</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Maelstrom 2410 (110V)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:57:22.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719880128785</udiDi>
    <basicUdiDi>471988012S04LG</basicUdiDi>
    <tradeName>04719880128785</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taiwan Advanced Nanotech Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000019040</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Maelstrom Switch 8 (110V-240V)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:57:18.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719880128648</udiDi>
    <basicUdiDi>471988012S04LG</basicUdiDi>
    <tradeName>04719880128648</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Taiwan Advanced Nanotech Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000019040</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Maelstrom Switch 8</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:57:17.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262367270014</udiDi>
    <basicUdiDi>B-04262367270014</basicUdiDi>
    <tradeName>04262367270014</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dermagnostix GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXA0000082</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:57:17.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976457970927</udiDi>
    <basicUdiDi>697645797FYT2G</basicUdiDi>
    <tradeName>EUYI Nucleic Acid Extraction Reagent (Manual method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100FYT-96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:02:46.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260711</udiDi>
    <basicUdiDi>4049095ZUNITY0000PA</basicUdiDi>
    <tradeName>04049095260711</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZUNITY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:21.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260735</udiDi>
    <basicUdiDi>4049095ZUNITY0000PA</basicUdiDi>
    <tradeName>04049095260735</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZUNITY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:21.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260759</udiDi>
    <basicUdiDi>4049095ZUNITY0000PA</basicUdiDi>
    <tradeName>04049095260759</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZUNITY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:21.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049095260766</udiDi>
    <basicUdiDi>4049095ZUNITY0000PA</basicUdiDi>
    <tradeName>04049095260766</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZUNITY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:40:21.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974900600114</udiDi>
    <basicUdiDi>697490060SWSI-0243</basicUdiDi>
    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWAI-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:51:19.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974900600121</udiDi>
    <basicUdiDi>697490060SWSI-0243</basicUdiDi>
    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWSI-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:51:19.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974900600138</udiDi>
    <basicUdiDi>697490060SWSI-0243</basicUdiDi>
    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWSI-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:51:19.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974900600145</udiDi>
    <basicUdiDi>697490060SWSI-0243</basicUdiDi>
    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWSI-05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:51:19.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>16974900600244</udiDi>
    <basicUdiDi>697490060SWSI-0243</basicUdiDi>
    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MANO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:51:19.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975412631016</udiDi>
    <basicUdiDi>697541263PCRSPB</basicUdiDi>
    <tradeName>Real-time PCR system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bio-gener Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027988</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q9604</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:50:57.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975412631023</udiDi>
    <basicUdiDi>697541263PCRSPB</basicUdiDi>
    <tradeName>Real-time PCR system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bio-gener Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027988</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q9606</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:50:57.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975412631030</udiDi>
    <basicUdiDi>697541263PCRSPB</basicUdiDi>
    <tradeName>Real-time PCR system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bio-gener Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027988</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q9606 Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:50:57.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975412631047</udiDi>
    <basicUdiDi>697541263PCRSPB</basicUdiDi>
    <tradeName>Real-time PCR system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bio-gener Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027988</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q9604 Pro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T14:50:57.348Z</lastUpdated>
  </row>
</eudamedExport>