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    <basicUdiDi>8905459MHVWRPDJX</basicUdiDi>
    <tradeName>08905459006660</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>HVWRPD-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:16.474Z</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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    <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>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-07-222</reference>
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    <lastUpdated>2026-07-04T14:22:30.187Z</lastUpdated>
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    <udiDi>00608337001686</udiDi>
    <basicUdiDi>B-00608337001686</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Greece/Cyprus</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>1001-0629U</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:49.974Z</lastUpdated>
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    <udiDi>00608337001525</udiDi>
    <basicUdiDi>B-00608337001525</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Germany</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>1001-0602U</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:43.565Z</lastUpdated>
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    <udiDi>00608337001518</udiDi>
    <basicUdiDi>B-00608337001518</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, Spain/Portugal</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>1001-0601U</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:28.325Z</lastUpdated>
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    <udiDi>00608337001273</udiDi>
    <basicUdiDi>B-00608337001273</basicUdiDi>
    <tradeName>OraQuick HIV Self-Test</tradeName>
    <deviceName>OraQuick HIV Self-Test, Single Unit, CE, UK</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</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>1001-0600U</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:19:27.514Z</lastUpdated>
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    <udiDi>08905459004741</udiDi>
    <basicUdiDi>8905459HIVWBSFEL</basicUdiDi>
    <tradeName>08905459004741</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>HIVWBS-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:44:20.101Z</lastUpdated>
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    <udiDi>08905459004758</udiDi>
    <basicUdiDi>8905459HIVWBSFEL</basicUdiDi>
    <tradeName>08905459004758</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>HIVWBS-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:44:18.925Z</lastUpdated>
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    <udiDi>08905459004765</udiDi>
    <basicUdiDi>8905459HIVWBSFEL</basicUdiDi>
    <tradeName>08905459004765</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>HIVWBS-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:44:04.225Z</lastUpdated>
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    <udiDi>18906074564327</udiDi>
    <basicUdiDi>8905459MHVWRPDJX</basicUdiDi>
    <tradeName>MERISCREEN</tradeName>
    <deviceName>MERISCREEN HIV 1-2 WB</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>HVWRPD-01 HVWRPD-02 HVWRPD-06 HVWRPD-07 , 08, 09, 10, 11, 12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:38:51.218Z</lastUpdated>
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    <udiDi>00628347561079</udiDi>
    <basicUdiDi>62834756AL0220026A</basicUdiDi>
    <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>
    <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>A02-07-322P25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:25.385Z</lastUpdated>
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    <udiDi>06952999407497</udiDi>
    <basicUdiDi>B-06952999407497</basicUdiDi>
    <tradeName>06952999407497</tradeName>
    <deviceName>HIV 1/2/O Tri-line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)</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 Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHI-T402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:53.808Z</lastUpdated>
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    <udiDi>06952804810726</udiDi>
    <basicUdiDi>B-06952804810726</basicUdiDi>
    <tradeName>HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>HIV Rapid Test Device (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>HIV-W23</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:27:01.224Z</lastUpdated>
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    <udiDi>00628347561048</udiDi>
    <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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    <udiDi>00628347561086</udiDi>
    <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>
    <legislation>IVDR 2017/746</legislation>
    <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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