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<eudamedExport entity="devices">
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    <udiDi>00628347568085</udiDi>
    <basicUdiDi>B-00628347568085</basicUdiDi>
    <tradeName>MIRATECH</tradeName>
    <deviceName>Onestep Pregnancy Urine Tests for self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-02-122MT1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:05.474Z</lastUpdated>
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    <udiDi>00628347568061</udiDi>
    <basicUdiDi>B-00628347568061</basicUdiDi>
    <tradeName>apotekets</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Tests for self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-04-130AK2</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:04.671Z</lastUpdated>
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    <udiDi>00628347568047</udiDi>
    <basicUdiDi>B-00628347568047</basicUdiDi>
    <tradeName>THE NEW Test Days</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) Menopause Test kits for self-testing</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-04-130NTD1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:23:03.867Z</lastUpdated>
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    <udiDi>00628347564094</udiDi>
    <basicUdiDi>B-00628347564094</basicUdiDi>
    <tradeName>Artron Fecal Occult Blood (FOB)Test</tradeName>
    <deviceName>Fecal Occult Blood (FOB)Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A05-02-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:59.856Z</lastUpdated>
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    <udiDi>00628347563783</udiDi>
    <basicUdiDi>B-00628347563783</basicUdiDi>
    <tradeName>Artron Artron Multi-Drug Dip Card Test</tradeName>
    <deviceName>Artron Multi-Drug Dip Card Test (DOA-10)</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A04-18-140</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:59.072Z</lastUpdated>
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  <row>
    <udiDi>00628347561796</udiDi>
    <basicUdiDi>B-00628347561796</basicUdiDi>
    <tradeName>Artron Procalcitonin (PCT) Test</tradeName>
    <deviceName>Procalcitonin (PCT) Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160999</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03-23-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:58.272Z</lastUpdated>
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    <udiDi>00628347561604</udiDi>
    <basicUdiDi>B-00628347561604</basicUdiDi>
    <tradeName>Artron Dengue NS1 Antigen Test</tradeName>
    <deviceName>Dengue NS1 Antigen Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03-22-222</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:57.458Z</lastUpdated>
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    <udiDi>00628347561383</udiDi>
    <basicUdiDi>B-00628347561383</basicUdiDi>
    <tradeName>Artron ONE STEP Tuberculosis Antibody (TB Ab) Test</tradeName>
    <deviceName>ONE STEP Tuberculosis Antibody (TB Ab) Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</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>A03-07-222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:53.460Z</lastUpdated>
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  <row>
    <udiDi>00628347561222</udiDi>
    <basicUdiDi>B-00628347561222</basicUdiDi>
    <tradeName>Artron Helicobacter pylori (HP) Antigen Test</tradeName>
    <deviceName>Helicobacter pylori (HP) Antigen Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-11-422</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:52.655Z</lastUpdated>
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  <row>
    <udiDi>00628347561178</udiDi>
    <basicUdiDi>B-00628347561178</basicUdiDi>
    <tradeName>Artron Helicobacter Pylori (HP) Antibody Test</tradeName>
    <deviceName>Helicobacter Pylori (HP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-11-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:51.876Z</lastUpdated>
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  <row>
    <udiDi>00628347561123</udiDi>
    <basicUdiDi>B-00628347561123</basicUdiDi>
    <tradeName>Artron One Step Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Treponema Pallidum (TP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-09-322</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:51.065Z</lastUpdated>
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    <udiDi>00628347561062</udiDi>
    <basicUdiDi>B-00628347561062</basicUdiDi>
    <tradeName>Artron HlV, HBsAg &amp; HCV Combo Test</tradeName>
    <deviceName>HlV, HBsAg &amp; HCV Combo Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-20-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:47.057Z</lastUpdated>
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  <row>
    <udiDi>00628347561116</udiDi>
    <basicUdiDi>B-00628347561116</basicUdiDi>
    <tradeName>Artron One Step Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Treponema Pallidum (TP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-09-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:46.257Z</lastUpdated>
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    <udiDi>00628347561109</udiDi>
    <basicUdiDi>B-00628347561109</basicUdiDi>
    <tradeName>Artron One Step Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Treponema Pallidum (TP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-09-213</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:45.549Z</lastUpdated>
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    <udiDi>00628347561024</udiDi>
    <basicUdiDi>B-00628347561024</basicUdiDi>
    <tradeName>Artron Human lmmunodeficiency Virus 1/2 (HMl2l Antibody Test</tradeName>
    <deviceName>Human immunodeficiency Virus 1/2 (HIV 1/2) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-07-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:30.187Z</lastUpdated>
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    <udiDi>00628347560973</udiDi>
    <basicUdiDi>B-00628347560973</basicUdiDi>
    <tradeName>Artron Hepatitis C Virus (HCV) Antibody Test</tradeName>
    <deviceName>Hepatitis C Virus (HCV) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-06-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:28.589Z</lastUpdated>
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    <udiDi>00628347560874</udiDi>
    <basicUdiDi>B-00628347560874</basicUdiDi>
    <tradeName>Artron Hepatitis B Virus Surface Antigen (HBsAg) Test</tradeName>
    <deviceName>Hepatitis B Virus Surface Antigen (HBsAg) Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-01-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:27.796Z</lastUpdated>
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    <udiDi>00628347560478</udiDi>
    <basicUdiDi>B-00628347560478</basicUdiDi>
    <tradeName>Artron Human Chorionic Gonadotropin (HCG) Test For self-testing(Ultra Sensitivity)</tradeName>
    <deviceName>Artron Human Chorionic Gonadotropin (HCG) Test For self-testing(Ultra Sensitivity)</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-02-130</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:26.190Z</lastUpdated>
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    <udiDi>00628347560454</udiDi>
    <basicUdiDi>B-00628347560454</basicUdiDi>
    <tradeName>Artron Onestep Pregnancy Urine Tests for Self- testing (Regular)</tradeName>
    <deviceName>Artron Human Chorionic Gonadotropin (HCG) Test For self-testing(Regular)</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01-01-130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:23.799Z</lastUpdated>
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    <udiDi>00628347561093</udiDi>
    <basicUdiDi>62834756AL02090279</basicUdiDi>
    <tradeName>Acmex Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Syphilis Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM02-09-322P</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:27.826Z</lastUpdated>
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