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    <lastUpdated>2026-07-07T01:13:26.788Z</lastUpdated>
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    <manufacturerName>Devyser AB</manufacturerName>
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    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
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    <reference>8-A012.2-13</reference>
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    <lastUpdated>2026-07-07T01:13:21.982Z</lastUpdated>
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    <basicUdiDi>B-07350040630648</basicUdiDi>
    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A045</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:20.361Z</lastUpdated>
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    <udiDi>07350040630624</udiDi>
    <basicUdiDi>B-07350040630624</basicUdiDi>
    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:19.561Z</lastUpdated>
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    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:17.977Z</lastUpdated>
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    <tradeName>Devyser Extend v2</tradeName>
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    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A015.2-100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:15.563Z</lastUpdated>
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    <tradeName>Devyser Compact v3</tradeName>
    <deviceName>Devyser Compact v3</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A017.3-100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:13.974Z</lastUpdated>
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    <udiDi>07350040630549</udiDi>
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    <tradeName>Devyser Compact v3</tradeName>
    <deviceName>Devyser Compact v3</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A017.3-50</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:13.168Z</lastUpdated>
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    <udiDi>07350040630532</udiDi>
    <basicUdiDi>B-07350040630532</basicUdiDi>
    <tradeName>Devyser Compavt v3</tradeName>
    <deviceName>Devyser Compact v3</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A017.3-25</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:11.566Z</lastUpdated>
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    <udiDi>07350040630525</udiDi>
    <basicUdiDi>B-07350040630525</basicUdiDi>
    <tradeName>Devyser Complete v2</tradeName>
    <deviceName>Devyser Complete v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A011.2-100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:09.176Z</lastUpdated>
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    <tradeName>Devyser Complete v2</tradeName>
    <deviceName>Devyser Complete v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A011.2-50</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:07.558Z</lastUpdated>
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    <basicUdiDi>B-07350040630501</basicUdiDi>
    <tradeName>Devyser Complete v2</tradeName>
    <deviceName>Devyser Complete v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A011.2-25</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:06.755Z</lastUpdated>
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    <basicUdiDi>B-07350040630495</basicUdiDi>
    <tradeName>Devyser CVD</tradeName>
    <deviceName>Devyser CVD</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A036</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:05.160Z</lastUpdated>
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    <tradeName>Devyser Thrombophilia</tradeName>
    <deviceName>Devyser Thrombophilia</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:02.752Z</lastUpdated>
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    <tradeName>EUYI β-Globin Gene Variation Test (PCR-RDB)</tradeName>
    <deviceName>EUYI β-Globin Gene Variation Test (PCR-RDB)</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100THV-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:21.783Z</lastUpdated>
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    <tradeName>EUYI β-Globin Gene Variation Test</tradeName>
    <deviceName>EUYI β-Globin Gene Variation Test</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034584</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <tradeName>EUYI α-Thalassemia Genotyping Kit (Nondeletion)</tradeName>
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    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
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    <tradeName>EUYI α-Thalassemia Test (Gap-PCR)</tradeName>
    <deviceName>EUYI α-Thalassemia Test (Gap-PCR)</deviceName>
    <manufacturerName>Shenzhen YOUYI Bioscience Ltd.</manufacturerName>
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    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100THA-24</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:08.988Z</lastUpdated>
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