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<eudamedExport entity="devices">
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    <udiDi>06976202762227</udiDi>
    <basicUdiDi>B-06976202762227</basicUdiDi>
    <tradeName>C. difficile Toxin A/B Rapid Test</tradeName>
    <deviceName>C. difficile Toxin A/B 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>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GICD-622</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:38.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762203</udiDi>
    <basicUdiDi>B-06976202762203</basicUdiDi>
    <tradeName>S.pneumoniae Rapid Test</tradeName>
    <deviceName>S.pneumoniae 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>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GISPNE-502</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:33.535Z</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>06976202762159</udiDi>
    <basicUdiDi>B-06976202762159</basicUdiDi>
    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName>Strep A 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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIST-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:25.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762135</udiDi>
    <basicUdiDi>B-06976202762135</basicUdiDi>
    <tradeName>Syphilis Rapid Test</tradeName>
    <deviceName>Syphilis 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>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GISY-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:20.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762074</udiDi>
    <basicUdiDi>B-06976202762074</basicUdiDi>
    <tradeName>Gonorrhea Rapid Test</tradeName>
    <deviceName>Gonorrhea 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIGON-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:11.948Z</lastUpdated>
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  <row>
    <udiDi>06976202762005</udiDi>
    <basicUdiDi>B-06976202762005</basicUdiDi>
    <tradeName>Campylobacter Rapid Test</tradeName>
    <deviceName>Campylobacter 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GICB-A602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:34:31.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440201540</udiDi>
    <basicUdiDi>84354402IDXGASTROB_CA5W</basicUdiDi>
    <tradeName>CerTest Campylobacter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA820001VC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:06.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435440207351</udiDi>
    <basicUdiDi>84354402IDXGASTROB_CA5W</basicUdiDi>
    <tradeName>CerTest Campylobacter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA820001VCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:49:56.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204552</udiDi>
    <basicUdiDi>B-06975166204552</basicUdiDi>
    <tradeName>06975166204552</tradeName>
    <deviceName>Neisseria Gonorrhoeae Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:04:08.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204545</udiDi>
    <basicUdiDi>B-06975166204545</basicUdiDi>
    <tradeName>06975166204545</tradeName>
    <deviceName>Neisseria Gonorrhoeae Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:04:07.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204538</udiDi>
    <basicUdiDi>B-06975166204538</basicUdiDi>
    <tradeName>06975166204538</tradeName>
    <deviceName>Neisseria Gonorrhoeae Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:04:06.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204521</udiDi>
    <basicUdiDi>B-06975166204521</basicUdiDi>
    <tradeName>06975166204521</tradeName>
    <deviceName>Neisseria Gonorrhoeae Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 Test/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:04:02.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204422</udiDi>
    <basicUdiDi>B-06975166204422</basicUdiDi>
    <tradeName>06975166204422</tradeName>
    <deviceName>H. pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:33.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204415</udiDi>
    <basicUdiDi>B-06975166204415</basicUdiDi>
    <tradeName>06975166204415</tradeName>
    <deviceName>H. pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:32.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204408</udiDi>
    <basicUdiDi>B-06975166204408</basicUdiDi>
    <tradeName>06975166204408</tradeName>
    <deviceName>H. pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:31.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166204392</udiDi>
    <basicUdiDi>B-06975166204392</basicUdiDi>
    <tradeName>06975166204392</tradeName>
    <deviceName>H. pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:30.914Z</lastUpdated>
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  <row>
    <udiDi>06975166204385</udiDi>
    <basicUdiDi>B-06975166204385</basicUdiDi>
    <tradeName>06975166204385</tradeName>
    <deviceName>H. pylori Antigen Rapid Test</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 Test/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:27.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201490</udiDi>
    <basicUdiDi>B-06975166201490</basicUdiDi>
    <tradeName>06975166201490</tradeName>
    <deviceName>Treponema pallidum Antibody Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:13.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975166201483</udiDi>
    <basicUdiDi>B-06975166201483</basicUdiDi>
    <tradeName>06975166201483</tradeName>
    <deviceName>Treponema pallidum Antibody Assay Kit(Colloidal gold)</deviceName>
    <manufacturerName>Avioq Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048146</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:03:12.507Z</lastUpdated>
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