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<eudamedExport entity="devices">
  <row>
    <udiDi>D-4680008050206VGET</udiDi>
    <basicUdiDi>B-4680008050206VGET</basicUdiDi>
    <tradeName>AMA RUT Pro (block of 24)</tradeName>
    <deviceName>Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Pro)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0206</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:47.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050205VEEJ</udiDi>
    <basicUdiDi>B-4680008050205VEEJ</basicUdiDi>
    <tradeName>AMA RUT Expert</tradeName>
    <deviceName>Helicobacter pylori AMA RAPID UREASE TEST (AMA RUT Expert)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0205</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:45.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050109VHEZ</udiDi>
    <basicUdiDi>B-4680008050109VHEZ</basicUdiDi>
    <tradeName>HELIC ABT Reader indicator tube kit (30 pcs)</tradeName>
    <deviceName>HELIC ABT Reader indicator tube kit (30 pcs)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0109</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:43.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050107VDEF</udiDi>
    <basicUdiDi>B-4680008050107VDEF</basicUdiDi>
    <tradeName>HELIC ABT Reader indicator tube kit (1 pcs)</tradeName>
    <deviceName>HELIC ABT Reader indicator tube kit (1 pcs)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0107</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:41.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4680008050106VBE6</udiDi>
    <basicUdiDi>B-4680008050106VBE6</basicUdiDi>
    <tradeName>HELIC ABT Reader indicator tube kit (50 pcs)</tradeName>
    <deviceName>HELIC ABT Reader indicator tube kit (50 pcs)</deviceName>
    <manufacturerName>«Association of Medicine and Analytics» Company Limited</manufacturerName>
    <manufacturerSrn>RU-MF-000036645</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0106</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:53:38.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-222901N-2069</udiDi>
    <basicUdiDi>B-222901N-2069</basicUdiDi>
    <tradeName>NADAL Strep A Test</tradeName>
    <deviceName>NADAL Strep A Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222901N-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:28:04.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-221901N-405U</udiDi>
    <basicUdiDi>B-221901N-405U</basicUdiDi>
    <tradeName>NADAL Strep A Test</tradeName>
    <deviceName>NADAL Strep A Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221901N-40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:28:00.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1O23C2Y5</udiDi>
    <basicUdiDi>B-1O23C2Y5</basicUdiDi>
    <tradeName>Rapid Leptospira IgG/IgM Combo Test</tradeName>
    <deviceName>Rapid Leptospira IgG/IgM Combo Test</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1O23C2-1-EU, 1O23C2-25-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:48.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698604161</udiDi>
    <basicUdiDi>B-16972698604161</basicUdiDi>
    <tradeName>B. pertussis Antigen Rapid Test</tradeName>
    <deviceName>B. pertussis Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P211106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:53:04.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698603720</udiDi>
    <basicUdiDi>B-16972698603720</basicUdiDi>
    <tradeName>Leptospira IgG/IgM Rapid Test</tradeName>
    <deviceName>Leptospira IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P231119</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:58.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698603706</udiDi>
    <basicUdiDi>B-16972698603706</basicUdiDi>
    <tradeName>Shigella Antigen Rapid Test</tradeName>
    <deviceName>Shigella Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:53.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698603690</udiDi>
    <basicUdiDi>B-16972698603690</basicUdiDi>
    <tradeName>Vibrio cholerae O1/O139 Antigen  Rapid Test</tradeName>
    <deviceName>Vibrio cholerae O1/O139 Antigen  Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221108</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:52.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698603683</udiDi>
    <basicUdiDi>B-16972698603683</basicUdiDi>
    <tradeName>Campylobacter Antigen Rapid Test</tradeName>
    <deviceName>Campylobacter Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221107</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:51.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698603645</udiDi>
    <basicUdiDi>B-16972698603645</basicUdiDi>
    <tradeName>Salmonella Typhi IgG/IgM Rapid Test</tradeName>
    <deviceName>Salmonella Typhi IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P231118</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:46.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698603669</udiDi>
    <basicUdiDi>B-16972698603669</basicUdiDi>
    <tradeName>Strep B Antigen Rapid Test</tradeName>
    <deviceName>Strep B Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090104</emdnCode>
    <emdnDescription>STREP. B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P281003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:45.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>16972698603652</udiDi>
    <basicUdiDi>B-16972698603652</basicUdiDi>
    <tradeName>Salmonella Typhi Antigen Rapid Test</tradeName>
    <deviceName>Salmonella Typhi Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013495</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P221106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:52:44.507Z</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>16952999401324</udiDi>
    <basicUdiDi>B-16952999401324</basicUdiDi>
    <tradeName>16952999401324</tradeName>
    <deviceName>Clearview® Strep A Cassette 2</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:56.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>16952999401317</udiDi>
    <basicUdiDi>B-16952999401317</basicUdiDi>
    <tradeName>16952999401317</tradeName>
    <deviceName>Clearview® Strep A Dipstick 2</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:52.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763167</udiDi>
    <basicUdiDi>B-15065023763167</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Strep A Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10017</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:20.149Z</lastUpdated>
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</eudamedExport>