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<eudamedExport entity="devices">
  <row>
    <udiDi>05060544100005</udiDi>
    <basicUdiDi>506054410Genefix8M</basicUdiDi>
    <tradeName>2 x GFX Saliva collectors ( includes funnel, tube filled with 1ml stabilization buffer, cap &amp; instruction manual)</tradeName>
    <deviceName>GeneFix DNA/RNA Collector, Non-sterile</deviceName>
    <manufacturerName>Cell Projects Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000002266</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GFX-01/02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:23:29.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956299701385</udiDi>
    <basicUdiDi>695629970005P7</basicUdiDi>
    <tradeName>Virus RNA Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:14:25.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956299701392</udiDi>
    <basicUdiDi>695629970005P7</basicUdiDi>
    <tradeName>Virus RNA Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:14:25.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956299701750</udiDi>
    <basicUdiDi>695629970005P7</basicUdiDi>
    <tradeName>Virus RNA Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SAMPLE COLLECTION SWABS WITH TRANSPORT MEDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401150</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:14:25.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956299702214</udiDi>
    <basicUdiDi>695629970005P7</basicUdiDi>
    <tradeName>Saliva DNA Sample Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401103</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:14:25.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260640119227</udiDi>
    <basicUdiDi>4260640110000072Z</basicUdiDi>
    <tradeName>Cortisol Test (v4)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>LykonDX GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000005929</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CORT-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:50:43.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325033078</udiDi>
    <basicUdiDi>4049325IVR06080001ATD</basicUdiDi>
    <tradeName>SaliCap Set</tradeName>
    <deviceName>SaliCap Set</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE69981</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:04:38.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325033085</udiDi>
    <basicUdiDi>4049325IVR06080001ATD</basicUdiDi>
    <tradeName>SaliCap Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE69985</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:40:08.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970927945378</udiDi>
    <basicUdiDi>697092794SAMPLING001UR</basicUdiDi>
    <tradeName>06970927945378</tradeName>
    <deviceName>Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)</deviceName>
    <manufacturerName>Zhejiang Aicor Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040036</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K13</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:41:21.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970927945361</udiDi>
    <basicUdiDi>697092794SAMPLING001UR</basicUdiDi>
    <tradeName>06970927945361</tradeName>
    <deviceName>Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)</deviceName>
    <manufacturerName>Zhejiang Aicor Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040036</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:41:15.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970927945354</udiDi>
    <basicUdiDi>697092794SAMPLING001UR</basicUdiDi>
    <tradeName>06970927945354</tradeName>
    <deviceName>Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)</deviceName>
    <manufacturerName>Zhejiang Aicor Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040036</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:41:13.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970927945347</udiDi>
    <basicUdiDi>697092794SAMPLING001UR</basicUdiDi>
    <tradeName>06970927945347</tradeName>
    <deviceName>Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)</deviceName>
    <manufacturerName>Zhejiang Aicor Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040036</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:41:12.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970927945330</udiDi>
    <basicUdiDi>697092794SAMPLING001UR</basicUdiDi>
    <tradeName>06970927945330</tradeName>
    <deviceName>Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)</deviceName>
    <manufacturerName>Zhejiang Aicor Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040036</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K09</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:41:11.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970927945323</udiDi>
    <basicUdiDi>697092794SAMPLING001UR</basicUdiDi>
    <tradeName>06970927945323</tradeName>
    <deviceName>Sampling Device Consumables (Specimen Container, Sample Collection Kit, Extraction Tube, Test Tube, Cuvette, Sample Cup, Saliva Collector, Test Tube Cap / Test Tube Plug, Test Tube Rack)</deviceName>
    <manufacturerName>Zhejiang Aicor Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040036</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K08</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-30T07:41:05.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895471916</udiDi>
    <basicUdiDi>697089547SC01Q3</basicUdiDi>
    <tradeName>06970895471916</tradeName>
    <deviceName>Saliva Collection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS01005F04C2010</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:49:17.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895471749</udiDi>
    <basicUdiDi>697089547SC01Q3</basicUdiDi>
    <tradeName>06970895471749</tradeName>
    <deviceName>Saliva Collection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS02005F04T2020</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:48:45.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970895470476</udiDi>
    <basicUdiDi>697089547SC01Q3</basicUdiDi>
    <tradeName>06970895470476</tradeName>
    <deviceName>Saliva Collection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS02005F06T2020</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:43:37.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>16942013203188</udiDi>
    <basicUdiDi>697023378SterileCups9J</basicUdiDi>
    <tradeName>Cups</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hubei V-Medical Products Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011268</manufacturerSrn>
    <authorisedRepresentativeName>RAFFIN MEDICAL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004632</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500516</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:50:02.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>16942013215693</udiDi>
    <basicUdiDi>697023378SterileCups9J</basicUdiDi>
    <tradeName>Cups</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hubei V-Medical Products Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011268</manufacturerSrn>
    <authorisedRepresentativeName>RAFFIN MEDICAL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004632</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:50:01.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>16942013213958</udiDi>
    <basicUdiDi>697023378SterileCups9J</basicUdiDi>
    <tradeName>Transparent measuring cup</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hubei V-Medical Products Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011268</manufacturerSrn>
    <authorisedRepresentativeName>RAFFIN MEDICAL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004632</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400724-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T03:38:15.596Z</lastUpdated>
  </row>
</eudamedExport>