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    <manufacturerName>Devyser AB</manufacturerName>
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    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
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    <lastUpdated>2026-06-30T09:48:13.528Z</lastUpdated>
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    <basicUdiDi>7350040638R107RF</basicUdiDi>
    <tradeName>One Lambda Devyser Chimerism (48 test)</tradeName>
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    <manufacturerName>Devyser AB</manufacturerName>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
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    <udiDi>07350040631904</udiDi>
    <basicUdiDi>7350040638R107RF</basicUdiDi>
    <tradeName>One Lambda Devyser Chimerism (24 test)</tradeName>
    <deviceName>One Lambda Devyser Chimerism</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <tradeName>One Lambda Devyser Accept cfDNA</tradeName>
    <deviceName>One Lambda Devyser Accept cfDNA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:02.700Z</lastUpdated>
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    <udiDi>07350040631744</udiDi>
    <basicUdiDi>7350040638R114RC</basicUdiDi>
    <tradeName>One Lambda Devyser Accept cfDNA</tradeName>
    <deviceName>One Lambda Devyser Accept cfDNA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010499</emdnCode>
    <emdnDescription>POLYMORPHISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R114-8</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:01.503Z</lastUpdated>
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    <udiDi>07350040631232</udiDi>
    <basicUdiDi>7350040638A017MN</basicUdiDi>
    <tradeName>Devyser Compact</tradeName>
    <deviceName>Devyser Compact</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R017-100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:48:00.297Z</lastUpdated>
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    <udiDi>07350040631225</udiDi>
    <basicUdiDi>7350040638A017MN</basicUdiDi>
    <tradeName>Devyser Compact</tradeName>
    <deviceName>Devyser Compact</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R017-50</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:47:54.300Z</lastUpdated>
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    <basicUdiDi>7350040638A017MN</basicUdiDi>
    <tradeName>Devyser Compact</tradeName>
    <deviceName>Devyser Compact</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-R017-25</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:47:53.103Z</lastUpdated>
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    <udiDi>06970341680459</udiDi>
    <basicUdiDi>69703416803202027HS</basicUdiDi>
    <tradeName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</tradeName>
    <deviceName>ß-THALASSAEMIA &amp; HbA1c Reagent Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320201205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:53:11.718Z</lastUpdated>
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    <udiDi>08908015304255</udiDi>
    <basicUdiDi>89080153043B1338LE</basicUdiDi>
    <tradeName>TRUPCR® IDH1/2 Detection &amp; Differentiation Kit</tradeName>
    <deviceName></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>3B1337</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:08.001Z</lastUpdated>
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    <udiDi>08908015304446</udiDi>
    <basicUdiDi>89080153043B1267LG</basicUdiDi>
    <tradeName>TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor &amp; Micro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1268</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:07.683Z</lastUpdated>
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    <udiDi>08908015304484</udiDi>
    <basicUdiDi>89080153043B1267LG</basicUdiDi>
    <tradeName>TRUPCR® BCR-ABL Kit – Quantitative Major (WHO IS) Minor &amp; Micro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1267/C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:07.591Z</lastUpdated>
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    <udiDi>08908015304507</udiDi>
    <basicUdiDi>89080153043B1291LD</basicUdiDi>
    <tradeName>TRUPCR® BCR-ABL Kit - Minor Quantitative</tradeName>
    <deviceName></deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010299</emdnCode>
    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1292</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:07.564Z</lastUpdated>
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    <udiDi>08908015304705</udiDi>
    <basicUdiDi>89080153043B1339LG</basicUdiDi>
    <tradeName>TRUPCR® MGMT Methylation Detection Kit</tradeName>
    <deviceName></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>
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    <emdnDescription>POLYGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1340</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T08:20:07.098Z</lastUpdated>
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    <tradeName>ThromboGUARD FII FV</tradeName>
    <deviceName></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>AB0040</reference>
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    <lastUpdated>2026-06-29T06:00:28.395Z</lastUpdated>
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    <udiDi>03760322820164</udiDi>
    <basicUdiDi>376032282CGENHLAB27J6</basicUdiDi>
    <tradeName>HLAB27GUARD</tradeName>
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    <manufacturerName>APPOLON BIOTECK</manufacturerName>
    <manufacturerSrn>FR-MF-000022234</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AB0039</reference>
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    <lastUpdated>2026-06-29T06:00:28.379Z</lastUpdated>
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    <basicUdiDi>B-06955792731097</basicUdiDi>
    <tradeName>06955792731097</tradeName>
    <deviceName>α-Thalassemia Gene Diagnostic Kit(gap-PCR)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S3045E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:29:57.316Z</lastUpdated>
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    <udiDi>06950996004541</udiDi>
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    <tradeName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</tradeName>
    <deviceName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7001B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:13.397Z</lastUpdated>
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    <tradeName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</tradeName>
    <deviceName>Survival Motor Neuron Genes 1, 2 (SMN1, SMN2) Exon Deletion Detection Kit (Fluorescence Quantitative PCR Method)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N7001A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:12.229Z</lastUpdated>
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    <basicUdiDi>89080153043B247NM</basicUdiDi>
    <tradeName>TRUPCR® HLA B-27 Real-Time PCR Kit</tradeName>
    <deviceName></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</reference>
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    <lastUpdated>2026-06-27T19:47:59.295Z</lastUpdated>
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