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    <tradeName>IGH Gene Clonality Assay</tradeName>
    <deviceName>IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
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    <reference>9-101-0081</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <basicUdiDi>B-00850052003142</basicUdiDi>
    <tradeName>IGH Gene Clonality Assay</tradeName>
    <deviceName>IGH Gene Clonality Assay for ABI Fluorescence Detection</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
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    <tradeName>00850024414044</tradeName>
    <deviceName>Prosigna Breast Cancer Prognostic Gene Signature Assay</deviceName>
    <manufacturerName>Veracyte, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000048711</manufacturerSrn>
    <authorisedRepresentativeName>Veracyte Global BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T08:00:41.545Z</lastUpdated>
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    <tradeName>Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)</tradeName>
    <deviceName>Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-GE010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:28.349Z</lastUpdated>
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    <udiDi>08720299808768</udiDi>
    <basicUdiDi>87202998087CBT7F</basicUdiDi>
    <tradeName>Clean Blood &amp; Tissue DNA Kit Dx</tradeName>
    <deviceName>Clean Blood &amp; Tissue DNA Kit Dx</deviceName>
    <manufacturerName>CleanNA B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000022870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBTDx-D0384</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:53:07.427Z</lastUpdated>
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    <udiDi>08683808252097</udiDi>
    <basicUdiDi>8683808252097CZ</basicUdiDi>
    <tradeName>Laborant Total Nucleic Acid Extraction NS Kit (480)</tradeName>
    <deviceName>Laborant Total Nucleic Acid Extraction NS Kit (480)</deviceName>
    <manufacturerName>ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000033765</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-01-480</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:16:15.558Z</lastUpdated>
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    <basicUdiDi>8683808252080CG</basicUdiDi>
    <tradeName>Laborant Total Nucleic Acid Extraction Kit (96)</tradeName>
    <deviceName>Laborant Total Nucleic Acid Extraction Kit (96)</deviceName>
    <manufacturerName>ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000033765</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-01-96</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:16:11.547Z</lastUpdated>
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    <basicUdiDi>8683808252073CK</basicUdiDi>
    <tradeName>Laborant Total Nucleic Acid Extraction Kit (48)</tradeName>
    <deviceName>Laborant Total Nucleic Acid Extraction Kit (48)</deviceName>
    <manufacturerName>ANT MEDİKAL İTHALAT İHRACAT PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000033765</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-01-48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:16:10.752Z</lastUpdated>
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    <basicUdiDi>8681957090409ED</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-GBA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GBA Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-GBA-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:20.164Z</lastUpdated>
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    <basicUdiDi>8681957090393EP</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-EXT1/EXT2 NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile EXT1 ve EXT2 Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-EXT-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:19.370Z</lastUpdated>
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    <basicUdiDi>8681957090386ES</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-HFE NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile HFE Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-HFE-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:18.559Z</lastUpdated>
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    <basicUdiDi>8681957090379EV</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-F7 NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile F7 Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-F7-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:17.756Z</lastUpdated>
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    <basicUdiDi>8681957090362EC</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-GAA NGS SEQUENCING KIT / Yeni Nesil Dizi Analizi ile GAA Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-GAA-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:13.751Z</lastUpdated>
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    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-VWF Yeni Nesil Dizi Analizi ile VWF Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-VWF-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:12.969Z</lastUpdated>
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    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-LIPODISTROFI Yeni Nesil Dizi Analizi ile Lipodistrofi Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-LD-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:11.348Z</lastUpdated>
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    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-GLA Yeni Nesil Dizi Analizi ile GLA Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-GLA-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:06.561Z</lastUpdated>
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    <tradeName>FAST WILSON SYNDROME Yeni Nesil Dizi Analizi ile ATP7B Mutasyonlarını Saptama Kiti</tradeName>
    <deviceName>FAST-TP53 Yeni Nesil Dizi Analizi ile TP53 Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-WLS-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:05.866Z</lastUpdated>
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    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-JK2 SEQUENCING KIT</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-JK-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:39:50.491Z</lastUpdated>
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    <tradeName>MULTİGEN</tradeName>
    <deviceName>FAST-FMF NGS Sequencing Kit</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-FMF-02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:39:48.096Z</lastUpdated>
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    <tradeName>MULTIGEN</tradeName>
    <deviceName>FAST-mtDNA NGS Sequencing Kit</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-MT-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:39:44.087Z</lastUpdated>
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