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    <basicUdiDi>924010SD94000KA</basicUdiDi>
    <tradeName>Allplex™ CT/NG/MG/TV Assay</tradeName>
    <deviceName>Allplex™ CT/NG/MG/TV 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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD9400X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:13:06.236Z</lastUpdated>
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    <udiDi>08809240102992</udiDi>
    <basicUdiDi>924010SD94000KA</basicUdiDi>
    <tradeName>Allplex™ CT/NG/MG/TV Assay</tradeName>
    <deviceName>Allplex™ CT/NG/MG/TV 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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD9400Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:13:05.041Z</lastUpdated>
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    <udiDi>08809240102985</udiDi>
    <basicUdiDi>924010SD10202G4</basicUdiDi>
    <tradeName>Allplex™ STI Essential Assay Q(MH,UU)</tradeName>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>SD10202X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:13:03.834Z</lastUpdated>
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    <udiDi>08809240102978</udiDi>
    <basicUdiDi>924010SD10202G4</basicUdiDi>
    <tradeName>Allplex™ STI Essential Assay Q(MH,UU)</tradeName>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>SD10201Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:13:02.645Z</lastUpdated>
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  <row>
    <udiDi>08809240102961</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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD10245Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:12:56.634Z</lastUpdated>
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    <udiDi>08809240102954</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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD9801Y</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:12:54.237Z</lastUpdated>
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  <row>
    <udiDi>08809240101230</udiDi>
    <basicUdiDi>924010GI10122BS</basicUdiDi>
    <tradeName>Allplex™ GI-Bacteria(I) plus Assay</tradeName>
    <deviceName>Allplex™ GI-Bacteria(I) plus 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>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GI10123Z</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:12:33.832Z</lastUpdated>
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    <udiDi>08809240101223</udiDi>
    <basicUdiDi>924010GI10122BS</basicUdiDi>
    <tradeName>Allplex™ GI-Bacteria(I) plus Assay</tradeName>
    <deviceName>Allplex™ GI-Bacteria(I) plus 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>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GI10122X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:12:27.848Z</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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11STI10A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:57.186Z</lastUpdated>
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    <udiDi>08684595033319</udiDi>
    <basicUdiDi>868511580PCR29JJ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>Salmonella/Camplyobacter/Yersinia enteroclitica Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP29P50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:30:08.648Z</lastUpdated>
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    <udiDi>08684595031650</udiDi>
    <basicUdiDi>868511580PCR29JJ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>Salmonella/Camplyobacter/Yersinia enteroclitica Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP29P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:30:00.249Z</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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABMNC3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:56.651Z</lastUpdated>
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    <udiDi>08684198020563</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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABMNC2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:53.041Z</lastUpdated>
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    <udiDi>08684198020556</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>
    <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>08683548257574</udiDi>
    <basicUdiDi>868511580PCR29JJ</basicUdiDi>
    <tradeName>ChainFor™</tradeName>
    <deviceName>Salmonella/Camplyobacter/Yersinia enteroclitica Genotyping qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP29P100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:29:24.238Z</lastUpdated>
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    <udiDi>08680018943180</udiDi>
    <basicUdiDi>868001894PCRRESCAPPN1004N</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Atypical CAP Panel Kit</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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCAP2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:44.023Z</lastUpdated>
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    <udiDi>08680018943173</udiDi>
    <basicUdiDi>868001894PCRRESCAPPN1004N</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Atypical CAP Panel Kit</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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCAP1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:42.851Z</lastUpdated>
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    <udiDi>08680018941346</udiDi>
    <basicUdiDi>868001894PCRRESCAPPN1004N</basicUdiDi>
    <tradeName>Anatolia Geneworks</tradeName>
    <deviceName>Bosphore Atypical CAP Panel Kit</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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABCAP3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:06:26.012Z</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>
    <emdnDescription>STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58123</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:59:30.537Z</lastUpdated>
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