<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987595301162</udiDi>
    <basicUdiDi>4987595PF1231KXJ</basicUdiDi>
    <tradeName>PATHFAST TB LAM Ag</tradeName>
    <deviceName>PATHFAST TB LAM Ag</deviceName>
    <manufacturerName>PHC Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008516</manufacturerSrn>
    <authorisedRepresentativeName>PHC Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002692</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30116</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:07.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>04562185395280</udiDi>
    <basicUdiDi>456018921000200273</basicUdiDi>
    <tradeName>04562185395280</tradeName>
    <deviceName>TRCR MB-Lysis Reagent</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0056202</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:01:04.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771104388</udiDi>
    <basicUdiDi>80567713110903Y</basicUdiDi>
    <tradeName>LIAISON® QuantiFERON®-TB Gold Plus II</tradeName>
    <deviceName>LIAISON® QuantiFERON®-TB Gold Plus II</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311090</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:10.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771104395</udiDi>
    <basicUdiDi>80567713110954A</basicUdiDi>
    <tradeName>LIAISON® QuantiFERON®-TB Gold Plus II</tradeName>
    <deviceName>LIAISON® QuantiFERON®-TB Gold Plus II</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311095</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:40:00.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771104180</udiDi>
    <basicUdiDi>80567713110503L</basicUdiDi>
    <tradeName>LIAISON® QuantiFERON®-TB Gold Plus</tradeName>
    <deviceName>LIAISON® QuantiFERON®-TB Gold Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:52.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056771103282</udiDi>
    <basicUdiDi>B-08056771103282</basicUdiDi>
    <tradeName>LIAISON® QuantiFERON®-TB Gold Plus</tradeName>
    <deviceName>LIAISON® QuantiFERON®-TB Gold Plus</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>311010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-22T22:39:34.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Nc046228Y</udiDi>
    <basicUdiDi>B-697994388Nc046228Y</basicUdiDi>
    <tradeName>D-697994388Nc046228Y</tradeName>
    <deviceName>Non-tuberculous Mycobacterium Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nc046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:28:13.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Fa046WR98</udiDi>
    <basicUdiDi>B-697994388Fa046WR98</basicUdiDi>
    <tradeName>D-697994388Fa046WR98</tradeName>
    <deviceName>Non-tuberculous Mycobacterium Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:03.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133045336</udiDi>
    <basicUdiDi>880613300610C4</basicUdiDi>
    <tradeName>AFIAS IGRA-TB</tradeName>
    <deviceName>AFIAS IGRA-TB</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-99</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:44:05.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860011123408</udiDi>
    <basicUdiDi>08600111234TM240B2</basicUdiDi>
    <tradeName>MYCOPROSAFE</tradeName>
    <deviceName>MYCOPROSAFE</deviceName>
    <manufacturerName>SALUBRIS, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000038921</manufacturerSrn>
    <authorisedRepresentativeName>DIAGNOTIS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000038248</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM240</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:53:41.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816387021039</udiDi>
    <basicUdiDi>081638702MycoNF</basicUdiDi>
    <tradeName>MycoDDR™ Trident™ Mycobacterium Digestion and Decontamination Reagent Sets</tradeName>
    <deviceName>Mycobacterium Digestion and Decontamination Reagent Sets</deviceName>
    <manufacturerName>IMMY, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000025165</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TBNN1010-2.5</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:21:34.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>30382904438068</udiDi>
    <basicUdiDi>038290CDZXTPZWHH</basicUdiDi>
    <tradeName>MAX</tradeName>
    <deviceName>BD MAX™ STR</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>443806</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:31:03.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885019710780</udiDi>
    <basicUdiDi>B-08885019710780</basicUdiDi>
    <tradeName>08885019710780</tradeName>
    <deviceName>abTES™ MTB Pro qPCR I Kit (100 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300194</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:43.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885019710728</udiDi>
    <basicUdiDi>B-08885019710728</basicUdiDi>
    <tradeName>08885019710728</tradeName>
    <deviceName>abTES™ MTB Pro qPCR I Kit (50 Reactions)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010799</emdnCode>
    <emdnDescription>MYCOBACTERIA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300193</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:20:21.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103876</udiDi>
    <basicUdiDi>B-08809240103876</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>TB10387Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:46:00.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103869</udiDi>
    <basicUdiDi>B-08809240103869</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>TB10386Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:56.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809240103852</udiDi>
    <basicUdiDi>B-08809240103852</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>TB10385Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T09:45:55.541Z</lastUpdated>
  </row>
  <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>
</eudamedExport>