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    <deviceName>Allplex™ STI Essential Assay Q(MH,UU)</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD10201Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:13:02.645Z</lastUpdated>
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    <basicUdiDi>924010SD98010L9</basicUdiDi>
    <tradeName>Allplex™ STI Essential Assay</tradeName>
    <deviceName>Allplex™ STI Essential Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD10245Z</reference>
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    <lastUpdated>2026-07-01T03:12:56.634Z</lastUpdated>
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    <basicUdiDi>924010SD98010L9</basicUdiDi>
    <tradeName>Allplex™ STI Essential Assay</tradeName>
    <deviceName>Allplex™ STI Essential Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD9801X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:12:55.432Z</lastUpdated>
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    <udiDi>08809240102947</udiDi>
    <basicUdiDi>924010SD98010L9</basicUdiDi>
    <tradeName>Allplex™ STI Essential Assay</tradeName>
    <deviceName>Allplex™ STI Essential Assay</deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD9801Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:12:54.237Z</lastUpdated>
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    <udiDi>08800111719004</udiDi>
    <basicUdiDi>88001117IPCA01MA10X9</basicUdiDi>
    <tradeName>STANDARD™ M10 STI Panel</tradeName>
    <deviceName>STANDARD™ M10 STI Panel</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11STI10A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:57.186Z</lastUpdated>
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    <udiDi>08684198020570</udiDi>
    <basicUdiDi>868001894PCRSTDCNMPN100E5</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore CT/NG/MG Panel Kit v1</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABMNC3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:56.651Z</lastUpdated>
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    <basicUdiDi>868001894PCRSTDCNMPN100E5</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore CT/NG/MG Panel Kit v1</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABMNC2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:53.041Z</lastUpdated>
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    <basicUdiDi>868001894PCRSTDCNMPN100E5</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore CT/NG/MG Panel Kit v1</deviceName>
    <manufacturerName>Anatolia Tani ve Biyoteknoloji Urunleri Arastirma Gelistirme San. ve Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000022487</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABMNC1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:50.659Z</lastUpdated>
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    <udiDi>08595696304010</udiDi>
    <basicUdiDi>859569630002Q5</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ MH/UU/UP Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof MH/UU/UP Multiplex PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58123</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:30.537Z</lastUpdated>
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    <basicUdiDi>859569630012Q8</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ CT/NG/MG Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof CT/NG/MG Multiplex PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58117</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:28.150Z</lastUpdated>
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    <tradeName>GeneProof CT/NG/MG Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof CT/NG/MG Multiplex PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNMX/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:19.737Z</lastUpdated>
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    <udiDi>08595696301941</udiDi>
    <basicUdiDi>859569630012Q8</basicUdiDi>
    <tradeName>GeneProof CT/NG/MG Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof CT/NG/MG Multiplex PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CNMX/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:18.533Z</lastUpdated>
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    <basicUdiDi>859569630002Q5</basicUdiDi>
    <tradeName>GeneProof MH/UU/UP Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof MH/UU/UP Multiplex PCR Kit</deviceName>
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    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MUPX/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:07.737Z</lastUpdated>
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    <tradeName>GeneProof MH/UU/UP Multiplex PCR Kit</tradeName>
    <deviceName>GeneProof MH/UU/UP Multiplex PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105070501</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MUPX/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:01.741Z</lastUpdated>
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    <tradeName>STD VIRPLEX® MINILAB PANEL</tradeName>
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    <manufacturerName>Vircell, S.L</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ML001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:33:44.875Z</lastUpdated>
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    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTPCR026-LP</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:33:42.356Z</lastUpdated>
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    <tradeName>Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)</tradeName>
    <deviceName>Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ02S1</reference>
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    <lastUpdated>2026-06-30T09:08:51.026Z</lastUpdated>
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    <tradeName>Neisseria gonorrhoeae, Chlamydia trachomatis Nucleic Acid Detection Kit (Fluorescent PCR)</tradeName>
    <deviceName>Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ02S1A</reference>
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    <lastUpdated>2026-06-30T09:08:49.846Z</lastUpdated>
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    <deviceName>Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ02M1</reference>
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    <lastUpdated>2026-06-30T09:08:48.637Z</lastUpdated>
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    <tradeName>Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR)</tradeName>
    <deviceName>Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit</deviceName>
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    <emdnCode>W0105070501</emdnCode>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ02L1</reference>
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    <lastUpdated>2026-06-30T09:08:42.622Z</lastUpdated>
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