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    <tradeName>05061059980465</tradeName>
    <deviceName>ZENA MAX Mumps Virus (MuV) Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040804</emdnCode>
    <emdnDescription>MUMPS / PAROTITIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD919169-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:46:18.554Z</lastUpdated>
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    <udiDi>05061059980410</udiDi>
    <basicUdiDi>B-05061059980410</basicUdiDi>
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    <deviceName>ZENA MAX Parvovirus B19 Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040509</emdnCode>
    <emdnDescription>PARVOVIRUS B 19 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD347532-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:46:11.764Z</lastUpdated>
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    <udiDi>05061059980397</udiDi>
    <basicUdiDi>B-05061059980397</basicUdiDi>
    <tradeName>05061059980397</tradeName>
    <deviceName>ZENA MAX Human Adenovirus (HAdV) Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040501</emdnCode>
    <emdnDescription>ADENOVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD145839-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:46:07.762Z</lastUpdated>
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    <udiDi>05061059980137</udiDi>
    <basicUdiDi>B-05061059980137</basicUdiDi>
    <tradeName>05061059980137</tradeName>
    <deviceName>ZENA MAX EBV Epstein-Barr Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040403</emdnCode>
    <emdnDescription>EBV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD889265-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:45:32.863Z</lastUpdated>
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    <udiDi>05061059980106</udiDi>
    <basicUdiDi>B-05061059980106</basicUdiDi>
    <tradeName>05061059980106</tradeName>
    <deviceName>ZENA MAX Monkeypox (MPXV) Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD919167-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:45:32.065Z</lastUpdated>
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    <udiDi>05061059980069</udiDi>
    <basicUdiDi>B-05061059980069</basicUdiDi>
    <tradeName>05061059980069</tradeName>
    <deviceName>ZENA MAX Influenza A(H1N1)pdm09 Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Advanced Molecular Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000043044</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KD145789-100</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:45:31.263Z</lastUpdated>
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    <udiDi>05060972700006</udiDi>
    <basicUdiDi>B-05060972700006</basicUdiDi>
    <tradeName>05060972700006</tradeName>
    <deviceName>YouSeq SARS-CoV-2 Multiplex qRT-PCR kit</deviceName>
    <manufacturerName>YouSeq Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000033902</manufacturerSrn>
    <authorisedRepresentativeName>Casus Consulting Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000023507</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>YS-qPX-CVD19-002-CE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T15:39:36.387Z</lastUpdated>
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    <udiDi>04897116730039</udiDi>
    <basicUdiDi>B-04897116730039</basicUdiDi>
    <tradeName>04897116730039</tradeName>
    <deviceName>INDICAID COVID-19 RAPID ANTIGEN TEST</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2110200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:17:33.051Z</lastUpdated>
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    <udiDi>04897036920411</udiDi>
    <basicUdiDi>B-04897036920411</basicUdiDi>
    <tradeName>04897036920411</tradeName>
    <deviceName>GenoScreen HPV-HR Plus Screening qPCR Assay</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041002</emdnCode>
    <emdnDescription>SCREENING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92042</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:40.958Z</lastUpdated>
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    <udiDi>04897036920404</udiDi>
    <basicUdiDi>B-04897036920404</basicUdiDi>
    <tradeName>04897036920404</tradeName>
    <deviceName>GenoScreen HPV-HR Screening qPCR Assay (Lyophilized)</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92041</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:36.951Z</lastUpdated>
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    <udiDi>04897036920398</udiDi>
    <basicUdiDi>B-04897036920398</basicUdiDi>
    <tradeName>04897036920398</tradeName>
    <deviceName>GenoScreen HPV-HR Screening qPCR Assay</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92040</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:36.152Z</lastUpdated>
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    <udiDi>04897036920381</udiDi>
    <basicUdiDi>B-04897036920381</basicUdiDi>
    <tradeName>04897036920381</tradeName>
    <deviceName>GenoQuest HPV 24 Genotyping qPCR Assay (Lyophilized)</deviceName>
    <manufacturerName>DiagCor Life Science Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000045806</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>92039</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T11:16:35.348Z</lastUpdated>
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    <udiDi>04562185405323</udiDi>
    <basicUdiDi>B-04562185405323</basicUdiDi>
    <tradeName>04562185405323</tradeName>
    <deviceName>TRCReady SARS-CoV-2 NE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040519</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0056110</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:50:34.081Z</lastUpdated>
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    <udiDi>04560189216426</udiDi>
    <basicUdiDi>B-04560189216426</basicUdiDi>
    <tradeName>04560189216426</tradeName>
    <deviceName>CL AIA-PACK SARS-CoV-2-Ag CONTROL SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041101</emdnCode>
    <emdnDescription>CORONAVIRUS AG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0029374</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:48:01.038Z</lastUpdated>
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    <udiDi>04560189216419</udiDi>
    <basicUdiDi>B-04560189216419</basicUdiDi>
    <tradeName>04560189216419</tradeName>
    <deviceName>CL AIA-PACK SARS-CoV-2-Ag SAMPLE TREATMENT SOLUTION</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041101</emdnCode>
    <emdnDescription>CORONAVIRUS AG</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0029574</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:48:00.241Z</lastUpdated>
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    <udiDi>04560189216303</udiDi>
    <basicUdiDi>B-04560189216303</basicUdiDi>
    <tradeName>04560189216303</tradeName>
    <deviceName>CL AIA-PACK SARS-CoV-2-Ab CONTROL SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029710</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:47:58.642Z</lastUpdated>
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    <udiDi>00810173656948</udiDi>
    <basicUdiDi>B-00810173656948</basicUdiDi>
    <tradeName>Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2HPV29A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:29.118Z</lastUpdated>
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    <basicUdiDi>B-00810173656931</basicUdiDi>
    <tradeName>Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)</tradeName>
    <deviceName>Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2HPV18A01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:28.045Z</lastUpdated>
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    <tradeName>++B379ZKM217Q</tradeName>
    <deviceName>ZIKV Detect™ 2.0 IgM Capture ELISA</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZKM2-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:27.287Z</lastUpdated>
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    <basicUdiDi>B-++B379WNMS1AC</basicUdiDi>
    <tradeName>++B379WNMS1AC</tradeName>
    <deviceName>West Nile Detect™ IgM Capture ELISA</deviceName>
    <manufacturerName>InBios International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020625</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040626</emdnCode>
    <emdnDescription>WEST NILE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WNMS-1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:41:25.464Z</lastUpdated>
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