<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809240101742</udiDi>
    <basicUdiDi>B-08809240101742</basicUdiDi>
    <tradeName>Allplex™ MTB/MDR/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDR/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB10174X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:44:09.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101735</udiDi>
    <basicUdiDi>B-08809240101735</basicUdiDi>
    <tradeName>Allplex™ MTB/MDR/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDR/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB10173Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:44:08.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101179</udiDi>
    <basicUdiDi>B-08809240101179</basicUdiDi>
    <tradeName>Allplex™ MTB/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB9500X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:55.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101148</udiDi>
    <basicUdiDi>B-08809240101148</basicUdiDi>
    <tradeName>Allplex™ MTB/MDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB9400Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:51.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101162</udiDi>
    <basicUdiDi>B-08809240101162</basicUdiDi>
    <tradeName>Allplex™ MTB/XDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/XDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB9500Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:50.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240101155</udiDi>
    <basicUdiDi>B-08809240101155</basicUdiDi>
    <tradeName>Allplex™ MTB/MDRe Detection</tradeName>
    <deviceName>Allplex™ MTB/MDRe Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB9400X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:49.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240100516</udiDi>
    <basicUdiDi>B-08809240100516</basicUdiDi>
    <tradeName>Anyplex™ MTB/NTMe Real-time Detection</tradeName>
    <deviceName>Anyplex™ MTB/NTMe Real-time Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB7202X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:00.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240100509</udiDi>
    <basicUdiDi>B-08809240100509</basicUdiDi>
    <tradeName>Anyplex™ MTB/NTMe Real-time Detection</tradeName>
    <deviceName>Anyplex™ MTB/NTMe Real-time Detection</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB7202Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:43:00.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300287</udiDi>
    <basicUdiDi>B-08800204300287</basicUdiDi>
    <tradeName>08800204300287</tradeName>
    <deviceName>RADI Shigella spp Detection KIT</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011614</emdnCode>
    <emdnDescription>SHIGELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:49.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300256</udiDi>
    <basicUdiDi>B-08800204300256</basicUdiDi>
    <tradeName>08800204300256</tradeName>
    <deviceName>RADI Salmonella spp Detection KIT</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011001</emdnCode>
    <emdnDescription>SALMONELLA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:43.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800204300249</udiDi>
    <basicUdiDi>B-08800204300249</basicUdiDi>
    <tradeName>08800204300249</tradeName>
    <deviceName>RADI Brucella spp Detection KIT</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011601</emdnCode>
    <emdnDescription>BRUCELLA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RB001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:14:43.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500115</udiDi>
    <basicUdiDi>B-08800097500115</basicUdiDi>
    <tradeName>PaxView TB MPCR-ULFA Kit</tradeName>
    <deviceName>PaxView TB MPCR-ULFA Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0431</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:19.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800097500009</udiDi>
    <basicUdiDi>B-08800097500009</basicUdiDi>
    <tradeName>PaxView TB/NTM MPCR-ULFA Kit</tradeName>
    <deviceName>PaxView TB/NTM MPCR-ULFA Kit</deviceName>
    <manufacturerName>PaxGenBio Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000024696</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V0401</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:24:11.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800076700451</udiDi>
    <basicUdiDi>B-08800076700451</basicUdiDi>
    <tradeName>HelicoSign Dry</tradeName>
    <deviceName>Helicosign Dry</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010499</emdnCode>
    <emdnDescription>H. PYLORI REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>HPYD050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:22:41.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056301159</udiDi>
    <basicUdiDi>B-08800056301159</basicUdiDi>
    <tradeName>PowerChek™ Salmonella Triplex Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ Salmonella Triplex Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011003</emdnCode>
    <emdnDescription>SALMONELLA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R0152E</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:05.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800056301005</udiDi>
    <basicUdiDi>B-08800056301005</basicUdiDi>
    <tradeName>PowerChek™ MTB/NTM Real-time PCR Kit</tradeName>
    <deviceName>PowerChek™ MTB/NTM Real-time PCR Kit</deviceName>
    <manufacturerName>KogeneBiotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045858</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IR0120</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:32:03.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719327497944</udiDi>
    <basicUdiDi>B-08719327497944</basicUdiDi>
    <tradeName>RealAccurate® Quadruplex Atypical Bacteria PCR kit</tradeName>
    <deviceName>RealAccurate® Quadruplex Atypical Bacteria PCR kit</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010503</emdnCode>
    <emdnDescription>LEGIONELLA DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF0966-R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:29.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719327116111</udiDi>
    <basicUdiDi>B-08719327116111</basicUdiDi>
    <tradeName>MeningoFinder® 2SMART</tradeName>
    <deviceName>MeningoFinder® 2SMART</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF1200-2S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:20.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08719326569963</udiDi>
    <basicUdiDi>B-08719326569963</basicUdiDi>
    <tradeName>RealAccurate® Quadruplex Mycobacteria PCR kit</tradeName>
    <deviceName>RealAccurate® Quadruplex Mycobacteria PCR kit</deviceName>
    <manufacturerName>PathoFinder B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000002704</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF0920-R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:06.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698898740072</udiDi>
    <basicUdiDi>B-08698898740072</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion MTBC QLP 2.1 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0030102</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:59:54.837Z</lastUpdated>
  </row>
</eudamedExport>