<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936983104807</udiDi>
    <basicUdiDi>6970277510001BXG</basicUdiDi>
    <tradeName>Legionella pneumophila Rapid Test</tradeName>
    <deviceName>Legionella pneumophila Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEG-N102-25</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:57:04.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILEG-R10269</udiDi>
    <basicUdiDi>B-ILEG-R10269</basicUdiDi>
    <tradeName>Legionella pneumophila Rapid Test Cassette</tradeName>
    <deviceName>Legionella pneumophila Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEG-R102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-27T03:36:54.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VILEG-101HD</udiDi>
    <basicUdiDi>B-VILEG-101HD</basicUdiDi>
    <tradeName>Legionella Pneumophila Rapid Test</tradeName>
    <deviceName>Legionella Pneumophila Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VILEG-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:45.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD106XA</udiDi>
    <basicUdiDi>B-GKPD106XA</basicUdiDi>
    <tradeName>Legionella pneumophila Ag Rapid Test Kit</tradeName>
    <deviceName>Legionella pneumophila Ag Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:37:11.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-84295779106XSJ9</udiDi>
    <basicUdiDi>B-84295779106XSJ9</basicUdiDi>
    <tradeName>SIMPLE Legio pneumo / STICK Legio pneumo</tradeName>
    <deviceName>SIMPLE Legio pneumo / STICK Legio pneumo</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.106.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:09:06.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698600101</udiDi>
    <basicUdiDi>B-16972698600101</basicUdiDi>
    <tradeName>Legionella Antigen Rapid Test Device</tradeName>
    <deviceName>Legionella Antigen Rapid Test Device</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P241110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:50:24.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998271875</udiDi>
    <basicUdiDi>B-08684998271875</basicUdiDi>
    <tradeName>RapidFor™ Legionella (FIA)</tradeName>
    <deviceName>Legionella (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:25.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548254221</udiDi>
    <basicUdiDi>B-08683548254221</basicUdiDi>
    <tradeName>RapidFor™Legionella pneumoniae Rapid Test Kit</tradeName>
    <deviceName>Legionella pneumoniae Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD92</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:29.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436592550937</udiDi>
    <basicUdiDi>B-08436592550937</basicUdiDi>
    <tradeName>Casete de Prueba Rápida de Legionella pneumophila</tradeName>
    <deviceName>Casete de Prueba Rápida de Legionella pneumophila</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEG-102</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:51:01.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763323</udiDi>
    <basicUdiDi>B-06976202763323</basicUdiDi>
    <tradeName>Legionella Pneumophila Rapid Test</tradeName>
    <deviceName>Legionella Pneumophila Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GILeg-502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:55.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762197</udiDi>
    <basicUdiDi>B-06976202762197</basicUdiDi>
    <tradeName>Legionella Rapid Test</tradeName>
    <deviceName>Legionella Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GILeg-502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:32.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700531700178</udiDi>
    <basicUdiDi>B-03700531700178</basicUdiDi>
    <tradeName>SYPHILITOP</tradeName>
    <deviceName>SYPHILITOP</deviceName>
    <manufacturerName>BIOSYNEX Swiss SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024717</manufacturerSrn>
    <authorisedRepresentativeName>BIOSYNEX</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000014076</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1030014</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:24:19.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532678592244</udiDi>
    <basicUdiDi>B-03532678592244</basicUdiDi>
    <tradeName>BIOSYNEX Legionella pneumophila BSS</tradeName>
    <deviceName>BIOSYNEX Legionella pneumophila BSS</deviceName>
    <manufacturerName>BIOSYNEX Swiss SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024717</manufacturerSrn>
    <authorisedRepresentativeName>BIOSYNEX</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000014076</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW30002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:46:25.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670100867</udiDi>
    <basicUdiDi>B-03532670100867</basicUdiDi>
    <tradeName>BIOSYNEX Legionella pneumophila BSX</tradeName>
    <deviceName>BIOSYNEX Legionella pneumophila BSX</deviceName>
    <manufacturerName>BIOSYNEX Swiss SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024717</manufacturerSrn>
    <authorisedRepresentativeName>BIOSYNEX</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000014076</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SW30002_BSX</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:37:57.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>08436610290777</udiDi>
    <basicUdiDi>843661029VRF00201QW</basicUdiDi>
    <tradeName>VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA</tradeName>
    <deviceName>VIRAPID® LEGIONELLA PNEUMOPHILA Ag FIA</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VRF002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:33:51.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581432160</udiDi>
    <basicUdiDi>B-06970581432160</basicUdiDi>
    <tradeName>Accu-Tell® Legionella Pneumophila Antigen Cassette (Urine)</tradeName>
    <deviceName>Accu-Tell® Legionella Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-IDT-B303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:49:04.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804811167</udiDi>
    <basicUdiDi>B-06952804811167</basicUdiDi>
    <tradeName>Legionella Antigen Rapid Test Device (Urine)</tradeName>
    <deviceName>Legionella Urinary Antigen test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LEG-U23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:16.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983115674</udiDi>
    <basicUdiDi>6970277510001BXG</basicUdiDi>
    <tradeName>Legionella pneumophila Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEG-N102B-10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:11.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983115681</udiDi>
    <basicUdiDi>6970277510001BXG</basicUdiDi>
    <tradeName>Legionella pneumophila Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEG-N102B-25</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:11.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936983116046</udiDi>
    <basicUdiDi>6970277510001BXG</basicUdiDi>
    <tradeName>Legionella pneumophila Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILEG-N102J-10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:10.593Z</lastUpdated>
  </row>
</eudamedExport>