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    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL SE35</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001493-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:07.127Z</lastUpdated>
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    <udiDi>06974318131661</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL SE35</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001493-00</reference>
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    <lastUpdated>2026-07-08T03:45:06.555Z</lastUpdated>
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    <udiDi>06974318131678</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL SE35</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001493-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>06974318131685</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL SE35</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001493-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:06.288Z</lastUpdated>
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    <udiDi>06974318131692</udiDi>
    <basicUdiDi>697431813S-KitMW</basicUdiDi>
    <tradeName>Universal Sequencing Reaction Kit T7 App-D FCL SE35</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>940-001493-00</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:06.047Z</lastUpdated>
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    <udiDi>08595696304324</udiDi>
    <basicUdiDi>B-08595696304324</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ MTHFR A1298C PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR A1298C PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58425</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:34.353Z</lastUpdated>
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    <udiDi>08595696304317</udiDi>
    <basicUdiDi>B-08595696304317</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ MTHFR C677T PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR C677T PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58424</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:31.949Z</lastUpdated>
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    <udiDi>08595696304300</udiDi>
    <basicUdiDi>B-08595696304300</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ PAI1 Genotyping PCR Kit</tradeName>
    <deviceName>GeneProof PAI1 Genotyping PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58423</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:30.349Z</lastUpdated>
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    <udiDi>08595696304294</udiDi>
    <basicUdiDi>B-08595696304294</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Factor XIII V34L PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58422</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:29.547Z</lastUpdated>
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    <udiDi>08595696304287</udiDi>
    <basicUdiDi>B-08595696304287</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Factor V Leiden PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58421</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:27.949Z</lastUpdated>
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    <udiDi>08595696304270</udiDi>
    <basicUdiDi>B-08595696304270</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ Factor II Prothrombin PCR Kit</tradeName>
    <deviceName>GeneProof Factor II Prothrombin PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58420</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:25.544Z</lastUpdated>
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    <udiDi>08595696302733</udiDi>
    <basicUdiDi>B-08595696302733</basicUdiDi>
    <tradeName>GeneProof MTHFR C677T MC PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR C677T MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M677/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:03.929Z</lastUpdated>
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    <udiDi>08595696302726</udiDi>
    <basicUdiDi>B-08595696302726</basicUdiDi>
    <tradeName>GeneProof MTHFR A1298C MC PCR Kit</tradeName>
    <deviceName>GeneProof MTHFR A1298C MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1298/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:02.333Z</lastUpdated>
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    <udiDi>08595696302719</udiDi>
    <basicUdiDi>B-08595696302719</basicUdiDi>
    <tradeName>GeneProof Factor II Prothrombin MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor II Prothrombin MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010114</emdnCode>
    <emdnDescription>PROTHROMBIN MUTATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FII/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:59.936Z</lastUpdated>
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    <udiDi>08595696302702</udiDi>
    <basicUdiDi>B-08595696302702</basicUdiDi>
    <tradeName>GeneProof Factor V Leiden MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FV/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:58.339Z</lastUpdated>
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    <udiDi>08595696302689</udiDi>
    <basicUdiDi>B-08595696302689</basicUdiDi>
    <tradeName>GeneProof PAI-1 Genotyping MC PCR Kit</tradeName>
    <deviceName>GeneProof PAI-1 Genotyping MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010116</emdnCode>
    <emdnDescription>OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAI1/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:57.528Z</lastUpdated>
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    <udiDi>08595696302696</udiDi>
    <basicUdiDi>B-08595696302696</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXIII/MC/040</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:58:55.925Z</lastUpdated>
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    <udiDi>08594161959915</udiDi>
    <basicUdiDi>B-08594161959915</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXIII/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:39.389Z</lastUpdated>
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    <udiDi>08594161958529</udiDi>
    <basicUdiDi>B-08594161958529</basicUdiDi>
    <tradeName>GeneProof Factor XIII V34L MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor XIII V34L MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FXIII/MC/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:35.377Z</lastUpdated>
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    <udiDi>08594161958512</udiDi>
    <basicUdiDi>B-08594161958512</basicUdiDi>
    <tradeName>GeneProof Factor V Leiden MC PCR Kit</tradeName>
    <deviceName>GeneProof Factor V Leiden MC PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FV/MC/200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:49:34.607Z</lastUpdated>
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