<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800204300089</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300089</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:04:40.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300102</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300102</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KM003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:04:40.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300133</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300133</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OE005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:04:40.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300300</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300300</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:04:26.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300348</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300348</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:04:26.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300355</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300355</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:04:26.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300706</udiDi>
    <basicUdiDi>88002043RADIPREPSD</basicUdiDi>
    <tradeName>08800204300706</tradeName>
    <deviceName></deviceName>
    <manufacturerName>KH Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000017883</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:04:26.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111710032</udiDi>
    <basicUdiDi>88001117IPAA01MA01W2</basicUdiDi>
    <tradeName>STANDARD™ M10 Console</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>M10-01C/11M1011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:44.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800118510215</udiDi>
    <basicUdiDi>88001185HS0010203K</basicUdiDi>
    <tradeName>08800118510215</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genesystem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022998</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>Artık piyasada değil</deviceStatus>
    <reference>1199100300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:41.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800118510222</udiDi>
    <basicUdiDi>88001185HS0010203K</basicUdiDi>
    <tradeName>08800118510222</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genesystem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022998</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>Artık piyasada değil</deviceStatus>
    <reference>1199100400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:41.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800118510321</udiDi>
    <basicUdiDi>88001185HS0010303N</basicUdiDi>
    <tradeName>08800118510321</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genesystem Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022998</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>Artık piyasada değil</deviceStatus>
    <reference>1399100300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:41.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879623</udiDi>
    <basicUdiDi>B-05391513879623</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 2 plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - VP2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:42.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879616</udiDi>
    <basicUdiDi>B-05391513879616</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 1 plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - VP1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:41.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879609</udiDi>
    <basicUdiDi>B-05391513879609</basicUdiDi>
    <tradeName>EntericBio® Dx plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - GPDx</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:40.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879593</udiDi>
    <basicUdiDi>B-05391513879593</basicUdiDi>
    <tradeName>EntericBio® Viral Panel 3 plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - VP3</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:39.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879579</udiDi>
    <basicUdiDi>B-05391513879579</basicUdiDi>
    <tradeName>EntericBio® CPE plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - CPE</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:37.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879562</udiDi>
    <basicUdiDi>0539151387CDIFFPY4</basicUdiDi>
    <tradeName>EntericBio® C.difficile plug-in</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - CDA</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:37.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391513879555</udiDi>
    <basicUdiDi>B-05391513879555</basicUdiDi>
    <tradeName>EntericBio® Gastro Panel 2 Plug-In</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Serosep Limited</manufacturerName>
    <manufacturerSrn>IE-MF-000020322</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050192</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBFFS - GP2A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T02:34:36.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860684</udiDi>
    <basicUdiDi>506065486GS-00X2F</basicUdiDi>
    <tradeName>Genedrive® System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-003 V6.0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:57.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860677</udiDi>
    <basicUdiDi>506065486GS-00X2F</basicUdiDi>
    <tradeName>Genedrive® System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-003 V4.0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:56.201Z</lastUpdated>
  </row>
</eudamedExport>