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    <udiDi>08684387213875</udiDi>
    <basicUdiDi>B-08684387213875</basicUdiDi>
    <tradeName>RevoDx Hepatitis A Virus Qualitative qPCR Kit</tradeName>
    <deviceName>RevoDx Hepatitis A Virus Qualitative qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202463-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:00:02.004Z</lastUpdated>
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  <row>
    <udiDi>08684387213868</udiDi>
    <basicUdiDi>B-08684387213868</basicUdiDi>
    <tradeName>RevoDx Hepatitis A Virus Qualitative qPCR Kit</tradeName>
    <deviceName>RevoDx Hepatitis A Virus Qualitative qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202463-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:00:01.186Z</lastUpdated>
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    <udiDi>08683548259707</udiDi>
    <basicUdiDi>B-08683548259707</basicUdiDi>
    <tradeName>LyoSens HAV Detection qPCR Kit</tradeName>
    <deviceName>HAV Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO44</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:20:59.708Z</lastUpdated>
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    <udiDi>06977903343227</udiDi>
    <basicUdiDi>B-06977903343227</basicUdiDi>
    <tradeName>06977903343227</tradeName>
    <deviceName>HAV IgM/IgG Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110236C25</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:33:01.612Z</lastUpdated>
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    <udiDi>06977903343210</udiDi>
    <basicUdiDi>B-06977903343210</basicUdiDi>
    <tradeName>06977903343210</tradeName>
    <deviceName>HAV IgM/IgG Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110236C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:59.211Z</lastUpdated>
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  <row>
    <udiDi>06976753476024</udiDi>
    <basicUdiDi>B-06976753476024</basicUdiDi>
    <tradeName>HAV IgM Rapid Test Device(Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A531401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:53.204Z</lastUpdated>
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    <udiDi>06976753474815</udiDi>
    <basicUdiDi>B-06976753474815</basicUdiDi>
    <tradeName>HAV IgGIgM Rapid Test Device(Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020199</emdnCode>
    <emdnDescription>HAV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A341401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:59:22.633Z</lastUpdated>
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  <row>
    <udiDi>06976202762623</udiDi>
    <basicUdiDi>B-06976202762623</basicUdiDi>
    <tradeName>HAV IgM Rapid Test</tradeName>
    <deviceName>HAV IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHAVm-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:50.434Z</lastUpdated>
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  <row>
    <udiDi>06976202762616</udiDi>
    <basicUdiDi>B-06976202762616</basicUdiDi>
    <tradeName>HAV IgG/IgM Test</tradeName>
    <deviceName>HAV IgG/IgM Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHAVb-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:34.366Z</lastUpdated>
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  <row>
    <udiDi>06976202762081</udiDi>
    <basicUdiDi>B-06976202762081</basicUdiDi>
    <tradeName>HAV IgG/IgM Rapid Test</tradeName>
    <deviceName>HAV IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIHAVb-422</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:13.643Z</lastUpdated>
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  <row>
    <udiDi>06974854620780</udiDi>
    <basicUdiDi>B-06974854620780</basicUdiDi>
    <tradeName>HAV lgM Rapid Test</tradeName>
    <deviceName>HAV lgM Rapid Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2202825</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:21.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854620735</udiDi>
    <basicUdiDi>B-06974854620735</basicUdiDi>
    <tradeName>HAV Ag One Step Rapid Test</tradeName>
    <deviceName>HAV Ag One Step Rapid Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020101</emdnCode>
    <emdnDescription>HAV ANTIGEN CONFIRMATORY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2202325</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:53:14.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974323018315</udiDi>
    <basicUdiDi>B-06974323018315</basicUdiDi>
    <tradeName>06974323018315</tradeName>
    <deviceName>Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:35.424Z</lastUpdated>
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  <row>
    <udiDi>06974323018308</udiDi>
    <basicUdiDi>B-06974323018308</basicUdiDi>
    <tradeName>06974323018308</tradeName>
    <deviceName>Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:34.621Z</lastUpdated>
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    <udiDi>06974323018292</udiDi>
    <basicUdiDi>B-06974323018292</basicUdiDi>
    <tradeName>06974323018292</tradeName>
    <deviceName>Hepatitis A Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:30.621Z</lastUpdated>
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    <udiDi>06974323010807</udiDi>
    <basicUdiDi>B-06974323010807</basicUdiDi>
    <tradeName>06974323010807</tradeName>
    <deviceName>Real-Time PCR Detection Kit for Hepatitis A Virus</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:43:46.254Z</lastUpdated>
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    <udiDi>06973914380442</udiDi>
    <basicUdiDi>B-06973914380442</basicUdiDi>
    <tradeName>06973914380442</tradeName>
    <deviceName>Hepatitis A virus （HAV）IgM Antibody Detection Kit (Magnetic Particle CLIA)</deviceName>
    <manufacturerName>Tianjin Bioscience Diagnostic Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023301</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H201.02.107C1.01X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:47:01.473Z</lastUpdated>
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    <udiDi>06971042229022</udiDi>
    <basicUdiDi>B-06971042229022</basicUdiDi>
    <tradeName>HAV Real Time RT-PCR Kit</tradeName>
    <deviceName>HAV Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020105</emdnCode>
    <emdnDescription>HEPATITIS A VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR-0001-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:12.875Z</lastUpdated>
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    <udiDi>15099590745127</udiDi>
    <basicUdiDi>150995901C39447SC</basicUdiDi>
    <tradeName>Access anti-HAV IgM</tradeName>
    <deviceName>C39447</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39447</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:55.896Z</lastUpdated>
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    <udiDi>15099590745097</udiDi>
    <basicUdiDi>150995901C39444S6</basicUdiDi>
    <tradeName>Access anti-HAV</tradeName>
    <deviceName>Access anti-HAV</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39444</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:39.848Z</lastUpdated>
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