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    <basicUdiDi>B-00863840000278</basicUdiDi>
    <tradeName>AmplideX SMA Plus Kit (50 rxn)</tradeName>
    <deviceName>AmplideX SMA Plus Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00055</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:05.426Z</lastUpdated>
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    <udiDi>00863840000261</udiDi>
    <basicUdiDi>B-00863840000261</basicUdiDi>
    <tradeName>AmplideX DM1 Dx Kit</tradeName>
    <deviceName>AmplideX DM1 Dx Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010118</emdnCode>
    <emdnDescription>MYOTONIC DYSTROPHY TYPE 1 OR STEINERT'S DISEASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76048</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:01.422Z</lastUpdated>
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    <udiDi>00850031753020</udiDi>
    <basicUdiDi>B-00850031753020</basicUdiDi>
    <tradeName>HemoTypeSC</tradeName>
    <deviceName>HemoTypeSC™ Test Kit – In Vitro Diagnostic – Pack of 50 Tests</deviceName>
    <manufacturerName>Silver Lake Research Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000027373</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010109</emdnCode>
    <emdnDescription>SICKLE CELL ANEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:55.163Z</lastUpdated>
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    <udiDi>00850017493049</udiDi>
    <basicUdiDi>B-00850017493049</basicUdiDi>
    <tradeName>AmplideX mPCR FMR1 Test</tradeName>
    <deviceName>AmplideX mPCR FMR1 Test</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A00401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:20.644Z</lastUpdated>
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    <udiDi>00850017493032</udiDi>
    <basicUdiDi>B-00850017493032</basicUdiDi>
    <tradeName>AmplideX HTT SNP/Repeat Phasing Test</tradeName>
    <deviceName>AmplideX HTT SNP/Repeat Phasing Test</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010107</emdnCode>
    <emdnDescription>HUNTINGTON CHOREA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>A00083</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:19.857Z</lastUpdated>
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    <udiDi>00850017493025</udiDi>
    <basicUdiDi>B-00850017493025</basicUdiDi>
    <tradeName>AmplideX SMA Plus Kit (100 rxn)</tradeName>
    <deviceName>AmplideX SMA Plus Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00056</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:19.065Z</lastUpdated>
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    <udiDi>D-00106010104013V8</udiDi>
    <basicUdiDi>B-00106010104013V8</basicUdiDi>
    <tradeName>D-00106010104013V8</tradeName>
    <deviceName>FMR1 CGG PCR</deviceName>
    <manufacturerName>Beijing Healthgene Laboratory Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000032465</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010104</emdnCode>
    <emdnDescription>FRAGILE X SYNDROME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:10:46.645Z</lastUpdated>
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    <udiDi>08906213930542</udiDi>
    <basicUdiDi>89080153043B1331KY</basicUdiDi>
    <tradeName>TRUPCR® MTHFR Mutation Detection Kit</tradeName>
    <deviceName>TRUPCR® MTHFR Mutation Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1331/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:15.443Z</lastUpdated>
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    <udiDi>08906213930511</udiDi>
    <basicUdiDi>89080153043B1321KV</basicUdiDi>
    <tradeName>TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit</tradeName>
    <deviceName>TRUPCR® Factor II Prothrombin Mutation (G20210A) Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1321/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:14.645Z</lastUpdated>
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    <udiDi>08906213930481</udiDi>
    <basicUdiDi>89080153043B1301KP</basicUdiDi>
    <tradeName>TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit</tradeName>
    <deviceName>TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1301/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:13.834Z</lastUpdated>
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    <udiDi>08906213930450</udiDi>
    <basicUdiDi>89080153043B247NM</basicUdiDi>
    <tradeName>TRUPCR® HLA B-27 Real-Time PCR Kit</tradeName>
    <deviceName>TRUPCR® HLA B-27 Real-Time PCR Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B247/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:13.039Z</lastUpdated>
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    <udiDi>8681957090349EL</udiDi>
    <basicUdiDi>8681957090349EL</basicUdiDi>
    <tradeName>MULTIGEN</tradeName>
    <deviceName>HEMOPHILIA B Yeni Nesil Dizi Analizi ile F9 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>W0106010117</emdnCode>
    <emdnDescription>OTHER HEMOPHILIA MUTATIONS (VWF, F8, F9)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-F9-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:12.155Z</lastUpdated>
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    <udiDi>8681957090072DY</udiDi>
    <basicUdiDi>8681957090072DY</basicUdiDi>
    <tradeName>8681957090072DY</tradeName>
    <deviceName>FAST-HBB NGS Sequencing Kit</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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-HBB-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:39:48.901Z</lastUpdated>
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    <udiDi>8681957090041DM</udiDi>
    <basicUdiDi>8681957090041DM</basicUdiDi>
    <tradeName>MULTİGEN</tradeName>
    <deviceName>Yeni Nesil Dizi Analizi ile CFTR 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>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-CF-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:39:46.490Z</lastUpdated>
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    <udiDi>08595223920812</udiDi>
    <basicUdiDi>85952239000005X4</basicUdiDi>
    <tradeName>gb GENETIC HFE</tradeName>
    <deviceName>gb GENETIC HFE</deviceName>
    <manufacturerName>GENERI BIOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000018857</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010105</emdnCode>
    <emdnDescription>HAEMOCHROMATOSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3208-025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:57:46.501Z</lastUpdated>
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    <basicUdiDi>7350134361789C</basicUdiDi>
    <tradeName>37350134361787</tradeName>
    <deviceName>SPOT-it TREC &amp; SMN1 Screening Kit</deviceName>
    <manufacturerName>ImmunoIVD AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034517</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-2020-TS</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:12:40.828Z</lastUpdated>
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    <tradeName>ThromboGUARD FII FV</tradeName>
    <deviceName>ThromboGUARD FII FV</deviceName>
    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010115</emdnCode>
    <emdnDescription>COMBINED FACTOR II / FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0023</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:25:31.674Z</lastUpdated>
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    <tradeName>SALSA MLPA Probemix P044 NF2</tradeName>
    <deviceName>SALSA MLPA Probemix P044 NF2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P044-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:41.874Z</lastUpdated>
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    <tradeName>SALSA MLPA Probemix P044 NF2</tradeName>
    <deviceName>SALSA MLPA Probemix P044 NF2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P044-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:39.478Z</lastUpdated>
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    <tradeName>SALSA MLPA Probemix P044 NF2</tradeName>
    <deviceName>SALSA MLPA Probemix P044 NF2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P044-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:38.273Z</lastUpdated>
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