<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809446480276</udiDi>
    <basicUdiDi>880944648QST09SA</basicUdiDi>
    <tradeName>Q-STATION ELITE</tradeName>
    <deviceName>Q-STATION ELITE</deviceName>
    <manufacturerName>PROTIA Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026040</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQST0901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:14.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809408862782</udiDi>
    <basicUdiDi>88094088SEP-001TD</basicUdiDi>
    <tradeName>08809408862782</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEPD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:43.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809408862041</udiDi>
    <basicUdiDi>88094088SEY-001WG</basicUdiDi>
    <tradeName>08809408862041</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEYD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:42.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809408861631</udiDi>
    <basicUdiDi>88094088SBT-001TJ</basicUdiDi>
    <tradeName>08809408861631</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBTD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:36.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809408861624</udiDi>
    <basicUdiDi>88094088SBF-001NQ</basicUdiDi>
    <tradeName>08809408861624</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBFD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:36.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317540207</udiDi>
    <basicUdiDi>880931754FRENDKQ</basicUdiDi>
    <tradeName>FREND System</tradeName>
    <deviceName>FREND System</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F10</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:16.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133010600</udiDi>
    <basicUdiDi>880613301060BU</basicUdiDi>
    <tradeName>AFIAS-1H</tradeName>
    <deviceName>AFIAS-1H</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRR054</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:39.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133010044</udiDi>
    <basicUdiDi>880613301004BJ</basicUdiDi>
    <tradeName>ichroma™ II</tradeName>
    <deviceName>ichroma™ II</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FPRR021</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:33.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806120502125</udiDi>
    <basicUdiDi>880612050212BK</basicUdiDi>
    <tradeName>08806120502125</tradeName>
    <deviceName>MESSIAH Gamma Counter</deviceName>
    <manufacturerName>Shinjin Medics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035809</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020203</emdnCode>
    <emdnDescription>GAMMA COUNTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DG02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:18.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806120502132</udiDi>
    <basicUdiDi>880612050213BM</basicUdiDi>
    <tradeName>08806120502132</tradeName>
    <deviceName>MESSIAH R4200</deviceName>
    <manufacturerName>Shinjin Medics Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000035809</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020203</emdnCode>
    <emdnDescription>GAMMA COUNTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MR01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:15.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111722691</udiDi>
    <basicUdiDi>88001117IPAA05IA01WJ</basicUdiDi>
    <tradeName>STANDARD™ i pre-Trigger</tradeName>
    <deviceName>STANDARD™ i pre-Trigger</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16PTR10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:48.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111722684</udiDi>
    <basicUdiDi>88001117IPAA06IA01WV</basicUdiDi>
    <tradeName>STANDARD™ i Trigger</tradeName>
    <deviceName>STANDARD™ i Trigger</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16TR10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:47.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111722677</udiDi>
    <basicUdiDi>88001117IPAA07IA01X8</basicUdiDi>
    <tradeName>STANDARD™ i Wash buffer</tradeName>
    <deviceName>STANDARD™ i Wash buffer</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>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16WB10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:46.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111722660</udiDi>
    <basicUdiDi>88001117IPAA04IA01W7</basicUdiDi>
    <tradeName>STANDARD™ i Cleanser</tradeName>
    <deviceName>STANDARD™ i Cleanser</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16CL10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:28.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111720260</udiDi>
    <basicUdiDi>88001117IPAA01IA02V8</basicUdiDi>
    <tradeName>STANDARD™ i2000</tradeName>
    <deviceName>STANDARD™ i2000</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>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16IA200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:27.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111720253</udiDi>
    <basicUdiDi>88001117IPAA01IA01V6</basicUdiDi>
    <tradeName>STANDARD™ i1000</tradeName>
    <deviceName>STANDARD™ i1000</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>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16IA100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:26.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800069000001</udiDi>
    <basicUdiDi>88000690ABSOLHY</basicUdiDi>
    <tradeName>ABOSOL</tradeName>
    <deviceName>ABSOL</deviceName>
    <manufacturerName>Absology Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026041</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABSOL-001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:23.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066300005</udiDi>
    <basicUdiDi>8800066300005WS</basicUdiDi>
    <tradeName>ASFA Scanner</tradeName>
    <deviceName>Immunofluorescence measuring device</deviceName>
    <manufacturerName>MBD Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026682</manufacturerSrn>
    <authorisedRepresentativeName>Javitech Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045915</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MBD-SC4C-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:17.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800047500110</udiDi>
    <basicUdiDi>88000475ATPI03GL</basicUdiDi>
    <tradeName>08800047500110</tradeName>
    <deviceName>PCLOK II</deviceName>
    <manufacturerName>PCL Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000029608</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCLOK II</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:12.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800037900104</udiDi>
    <basicUdiDi>880003790010AY</basicUdiDi>
    <tradeName>08800037900104</tradeName>
    <deviceName>SimplexTAS 101 Heating Block</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0001002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:13.036Z</lastUpdated>
  </row>
</eudamedExport>