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    <udiDi>08693285182718</udiDi>
    <basicUdiDi>B-08693285182718</basicUdiDi>
    <tradeName>08693285182718</tradeName>
    <deviceName>Anti-HIV 1/2 Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>RTHIV02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:29:30.659Z</lastUpdated>
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    <udiDi>08693285182633</udiDi>
    <basicUdiDi>B-08693285182633</basicUdiDi>
    <tradeName>08693285182633</tradeName>
    <deviceName>Anti-HIV 1/2 Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>THIV02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:27:50.834Z</lastUpdated>
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    <udiDi>08693285181308</udiDi>
    <basicUdiDi>B-08693285181308</basicUdiDi>
    <tradeName>08693285181308</tradeName>
    <deviceName>Anti-HIV 1/2 Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>IHIV01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:26:10.567Z</lastUpdated>
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    <udiDi>08693285181186</udiDi>
    <basicUdiDi>B-08693285181186</basicUdiDi>
    <tradeName>08693285181186</tradeName>
    <deviceName>Anti-HIV 1/2 Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>RTHIV01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:25:56.928Z</lastUpdated>
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    <udiDi>08693285181063</udiDi>
    <basicUdiDi>B-08693285181063</basicUdiDi>
    <tradeName>08693285181063</tradeName>
    <deviceName>Anti-HIV 1/2 Test</deviceName>
    <manufacturerName>TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.</manufacturerName>
    <manufacturerSrn>TR-MF-000028553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>THIV01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:25:38.566Z</lastUpdated>
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    <udiDi>06940131404992</udiDi>
    <basicUdiDi>69401314HIV002CG</basicUdiDi>
    <tradeName>06940131404992</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NewScen Coast Bio-Pharmaceutical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021934</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</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>HIV3-29202511000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:17:24.127Z</lastUpdated>
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    <udiDi>06940131405005</udiDi>
    <basicUdiDi>69401314HIV002CG</basicUdiDi>
    <tradeName>06940131405005</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NewScen Coast Bio-Pharmaceutical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021934</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</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>HIV3-29204017000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:17:24.112Z</lastUpdated>
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    <udiDi>06940131405012</udiDi>
    <basicUdiDi>69401314HIV002CG</basicUdiDi>
    <tradeName>06940131405012</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NewScen Coast Bio-Pharmaceutical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021934</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</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>HIV3-29200501000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:17:24.085Z</lastUpdated>
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    <udiDi>06940131405098</udiDi>
    <basicUdiDi>69401314HIV002CG</basicUdiDi>
    <tradeName>06940131405098</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NewScen Coast Bio-Pharmaceutical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021934</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</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>HIV3-29200201000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:17:24.047Z</lastUpdated>
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  <row>
    <udiDi>08905459004710</udiDi>
    <basicUdiDi>8905459HIVOSF9V</basicUdiDi>
    <tradeName>HIVFIND</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>UNKNOWN</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIVSST-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.169Z</lastUpdated>
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    <udiDi>08905459004727</udiDi>
    <basicUdiDi>8905459HIVOSF9V</basicUdiDi>
    <tradeName>HIVFIND</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>UNKNOWN</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIVSST-03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.147Z</lastUpdated>
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    <udiDi>08905459004734</udiDi>
    <basicUdiDi>8905459HIVOSF9V</basicUdiDi>
    <tradeName>HIVFIND</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>UNKNOWN</legislation>
    <emdnCode>W0105090302</emdnCode>
    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIVSST-04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:32.126Z</lastUpdated>
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  <row>
    <udiDi>06974674891421</udiDi>
    <basicUdiDi>B-06974674891421</basicUdiDi>
    <tradeName>Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)</tradeName>
    <deviceName>Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0034</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:12.641Z</lastUpdated>
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    <udiDi>06974674891414</udiDi>
    <basicUdiDi>B-06974674891414</basicUdiDi>
    <tradeName>Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)</tradeName>
    <deviceName>Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0033</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:11.046Z</lastUpdated>
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    <udiDi>06974674891407</udiDi>
    <basicUdiDi>B-06974674891407</basicUdiDi>
    <tradeName>Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)</tradeName>
    <deviceName>Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:11:10.240Z</lastUpdated>
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    <udiDi>06974443201864</udiDi>
    <basicUdiDi>B-06974443201864</basicUdiDi>
    <tradeName>Ebola Virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Ebola Virus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Shenzhen Reagent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047757</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNPT96029-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:08:52.501Z</lastUpdated>
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    <udiDi>06974443201833</udiDi>
    <basicUdiDi>B-06974443201833</basicUdiDi>
    <tradeName>Hantavirus Antigen Rapid Test Kit</tradeName>
    <deviceName>Hantavirus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Shenzhen Reagent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047757</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNPT96028-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:08:50.900Z</lastUpdated>
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    <udiDi>06974443201826</udiDi>
    <basicUdiDi>B-06974443201826</basicUdiDi>
    <tradeName>Hantavirus IgG/IgM Antibody Rapid Test Kit</tradeName>
    <deviceName>Hantavirus IgG/IgM Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Shenzhen Reagent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047757</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNPT96027-20</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:08:50.118Z</lastUpdated>
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    <udiDi>06974443201857</udiDi>
    <basicUdiDi>B-06974443201857</basicUdiDi>
    <tradeName>Ebola Virus Antigen Rapid Test Kit</tradeName>
    <deviceName>Ebola Virus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Shenzhen Reagent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047757</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNPT96029-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:08:48.600Z</lastUpdated>
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    <udiDi>06974443201819</udiDi>
    <basicUdiDi>B-06974443201819</basicUdiDi>
    <tradeName>Hantavirus IgG/IgM Antibody Rapid Test Kit</tradeName>
    <deviceName>Hantavirus IgG/IgM Antibody Rapid Test Kit</deviceName>
    <manufacturerName>Shenzhen Reagent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047757</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090399</emdnCode>
    <emdnDescription>RETROVIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNPT96027-01</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:08:34.841Z</lastUpdated>
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