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    <basicUdiDi>89080153043B1339LG</basicUdiDi>
    <tradeName>TRUPCR® MGMT Methylation Detection Kit</tradeName>
    <deviceName>TRUPCR® MGMT Methylation 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>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:31.781Z</lastUpdated>
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    <udiDi>08908015304088</udiDi>
    <basicUdiDi>89080153043B1267LG</basicUdiDi>
    <tradeName>TRUPCR® BCR-ABL1 Quantitative Kit – Major (WHO IS), Minor &amp; Micro</tradeName>
    <deviceName>TRUPCR® BCR-ABL1 Quantitative  Kit – Major (WHO IS), Minor &amp; Micro</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>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1267</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:26.142Z</lastUpdated>
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    <udiDi>08908015304033</udiDi>
    <basicUdiDi>89080153043B1338LE</basicUdiDi>
    <tradeName>TRUPCR® IDH1/2 Detection &amp; Differentiation Kit</tradeName>
    <deviceName>TRUPCR® IDH1/2 Detection &amp; Differentiation 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>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1338</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:25.347Z</lastUpdated>
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    <udiDi>08908015304026</udiDi>
    <basicUdiDi>89080153043B1291LD</basicUdiDi>
    <tradeName>TRUPCR® BCR-ABL1 Minor Quantitative Kit</tradeName>
    <deviceName>TRUPCR® BCR-ABL1 Minor Quantitative 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>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1291</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:24.540Z</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>
  </row>
  <row>
    <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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  <row>
    <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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  <row>
    <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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    <udiDi>37350134361787</udiDi>
    <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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    <udiDi>07350040632185</udiDi>
    <basicUdiDi>7350040638R200R6</basicUdiDi>
    <tradeName>Devyser Index Plate A</tradeName>
    <deviceName>Devyser Index Plate A</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R200</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:06.375Z</lastUpdated>
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    <udiDi>07350040632109</udiDi>
    <basicUdiDi>7350040638R207RL</basicUdiDi>
    <tradeName>Devyser Index Plate LB-192</tradeName>
    <deviceName>Devyser Index Plate LB-192</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R207</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:05.581Z</lastUpdated>
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    <udiDi>07350040632079</udiDi>
    <basicUdiDi>7350040638R402RL</basicUdiDi>
    <tradeName>560 Sizer Orange</tradeName>
    <deviceName>560 Sizer Orange</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R402</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:04.774Z</lastUpdated>
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    <udiDi>07350040632062</udiDi>
    <basicUdiDi>7350040638R401RJ</basicUdiDi>
    <tradeName>DEV-5 Dye Set, MultiCap</tradeName>
    <deviceName>DEV-5 Dye Set, MultiCap</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R401</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:51:00.775Z</lastUpdated>
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    <udiDi>07350040632055</udiDi>
    <basicUdiDi>7350040638R204RE</basicUdiDi>
    <tradeName>Devyser Library Clean</tradeName>
    <deviceName>Devyser Library Clean</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R204</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:50:59.976Z</lastUpdated>
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    <udiDi>07350040632048</udiDi>
    <basicUdiDi>7350040638R202RA</basicUdiDi>
    <tradeName>Devyser Index Plate LB-A</tradeName>
    <deviceName>Devyser Index Plate LB-A</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R202</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:50:59.173Z</lastUpdated>
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    <udiDi>05744003510313</udiDi>
    <basicUdiDi>574400351MFG03011085</basicUdiDi>
    <tradeName>NIFTY®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BGI EUROPE A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000014089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010306</emdnCode>
    <emdnDescription>MULTIPLE DETECTION OF CHROMOSOMAL DISORDERS TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFG030112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:44:12.579Z</lastUpdated>
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