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    <tradeName>Artron HIV Ab, HBsAg &amp; HCV Ab (3H) Combo Test (Artron 3H Combo Test)</tradeName>
    <deviceName>HIV Ab, HBsAg &amp; HCV Ab (3H) Combo Test (Artron 3H 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 Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-20-322P25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:26.164Z</lastUpdated>
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    <udiDi>00628347561031</udiDi>
    <basicUdiDi>62834756AL0207026X</basicUdiDi>
    <tradeName>Artron Human Immunodeficiency Virus (HIV 1/2) Antibody Test</tradeName>
    <deviceName>Human Immunodeficiency Virus (HIV 1/2) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:25.385Z</lastUpdated>
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    <udiDi>00628347560980</udiDi>
    <basicUdiDi>62834756AL0206026S</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>
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    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-06-322P25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:24.571Z</lastUpdated>
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    <udiDi>00628347560881</udiDi>
    <basicUdiDi>62834756AL0201025Z</basicUdiDi>
    <tradeName>Artron Hepatitis B Surface Antigen (HBsAg) Test</tradeName>
    <deviceName>Hepatitis B 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 Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-01-322P25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:18.981Z</lastUpdated>
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    <udiDi>00628347560928</udiDi>
    <basicUdiDi>62834756AL0201025Z</basicUdiDi>
    <tradeName>Acmex Hepatitis B Surface Antigen (HBsAg) Test</tradeName>
    <deviceName></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 D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM02-01-322P25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:55:49.656Z</lastUpdated>
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    <udiDi>00628347560997</udiDi>
    <basicUdiDi>62834756AL0206026S</basicUdiDi>
    <tradeName>Acmex Hepatitis C Virus (HCV) Antibody Test</tradeName>
    <deviceName></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 D</riskClass>
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    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM02-06-322P25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:55:49.605Z</lastUpdated>
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    <basicUdiDi>62834756AL0207026X</basicUdiDi>
    <tradeName>Acmex Human Immunodeficiency Virus 1/2 (HIV1/2) Antibody Test</tradeName>
    <deviceName></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 D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM02-07-322P25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:55:49.541Z</lastUpdated>
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    <basicUdiDi>62834756AL0220026A</basicUdiDi>
    <tradeName>Acmex HIV Ab, HBsAg &amp; HCV Ab (3H) Combo Test (Acmex 3H Combo Test)</tradeName>
    <deviceName></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 D</riskClass>
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    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM02-20-322P25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:55:49.476Z</lastUpdated>
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    <udiDi>00628347561130</udiDi>
    <basicUdiDi>62834756AL02090279</basicUdiDi>
    <tradeName>Artron Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName></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>A02-09-322P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:55:49.370Z</lastUpdated>
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