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    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:59.658Z</lastUpdated>
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    <udiDi>07350040631638</udiDi>
    <basicUdiDi>B-07350040631638</basicUdiDi>
    <tradeName>Devyser HBOC</tradeName>
    <deviceName>Devyser HBOC</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A111-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:58.834Z</lastUpdated>
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    <udiDi>07350040631614</udiDi>
    <basicUdiDi>B-07350040631614</basicUdiDi>
    <tradeName>Devyser Thalassemia</tradeName>
    <deviceName>Devyser Thalassemia</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A106-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:58.041Z</lastUpdated>
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    <udiDi>07350040631645</udiDi>
    <basicUdiDi>B-07350040631645</basicUdiDi>
    <tradeName>Devyser HBOC</tradeName>
    <deviceName>Devyser HBOC</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A111-48</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:57.268Z</lastUpdated>
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    <udiDi>07350040631607</udiDi>
    <basicUdiDi>B-07350040631607</basicUdiDi>
    <tradeName>Devyser Thalassemia</tradeName>
    <deviceName>Devyser Thalassemia</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A106-48</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:41.975Z</lastUpdated>
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    <udiDi>07350040631591</udiDi>
    <basicUdiDi>B-07350040631591</basicUdiDi>
    <tradeName>Devyser Thalassemia</tradeName>
    <deviceName>Devyser Thalassemia</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A106-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:39.574Z</lastUpdated>
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    <udiDi>07350040631270</udiDi>
    <basicUdiDi>B-07350040631270</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-96</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:37.973Z</lastUpdated>
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    <udiDi>07350040631263</udiDi>
    <basicUdiDi>B-07350040631263</basicUdiDi>
    <tradeName>Devyser BRCA</tradeName>
    <deviceName>Devyser BRCA</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060203</emdnCode>
    <emdnDescription>BRCA 1+2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A100-8</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:37.190Z</lastUpdated>
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    <udiDi>07350040631164</udiDi>
    <basicUdiDi>B-07350040631164</basicUdiDi>
    <tradeName>Devyser RHD</tradeName>
    <deviceName>Devyser RHD</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A060-390</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:35.722Z</lastUpdated>
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    <udiDi>07350040631133</udiDi>
    <basicUdiDi>B-07350040631133</basicUdiDi>
    <tradeName>Devyser RHD</tradeName>
    <deviceName>Devyser RHD</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A060</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:33.168Z</lastUpdated>
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    <udiDi>07350040630761</udiDi>
    <basicUdiDi>B-07350040630761</basicUdiDi>
    <tradeName>Devyser HFE v2</tradeName>
    <deviceName>Devyser HFE v2</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A030.2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:32.367Z</lastUpdated>
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    <udiDi>07350040630747</udiDi>
    <basicUdiDi>B-07350040630747</basicUdiDi>
    <tradeName>Devyser Extend M1 v2</tradeName>
    <deviceName>Devyser Extend M1 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-A015.2-M1</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:31.192Z</lastUpdated>
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    <udiDi>07350040630730</udiDi>
    <basicUdiDi>B-07350040630730</basicUdiDi>
    <tradeName>Devyser Extend v2</tradeName>
    <deviceName>Devyser Extend 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-A015.2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:28.376Z</lastUpdated>
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    <udiDi>07350040630723</udiDi>
    <basicUdiDi>B-07350040630723</basicUdiDi>
    <tradeName>Devyser Resolution XY v2</tradeName>
    <deviceName>Devyser Resolution XY 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-A012.2-XY</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:26.788Z</lastUpdated>
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    <udiDi>07350040630716</udiDi>
    <basicUdiDi>B-07350040630716</basicUdiDi>
    <tradeName>Devyser Resolution 21 v2</tradeName>
    <deviceName>Devyser Resolution 21 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-A012.2-21</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:25.969Z</lastUpdated>
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    <udiDi>07350040630709</udiDi>
    <basicUdiDi>B-07350040630709</basicUdiDi>
    <tradeName>Devyser Resolution 18 v2</tradeName>
    <deviceName>Devyser Resolution 18 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-A012.2-18</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:24.377Z</lastUpdated>
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    <udiDi>07350040630693</udiDi>
    <basicUdiDi>B-07350040630693</basicUdiDi>
    <tradeName>Devyser Resolution 13 v2</tradeName>
    <deviceName>Devyser Resolution 13 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-A012.2-13</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:21.982Z</lastUpdated>
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    <udiDi>07350040630648</udiDi>
    <basicUdiDi>B-07350040630648</basicUdiDi>
    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <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>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A045-8</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:19.561Z</lastUpdated>
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    <udiDi>07350040630617</udiDi>
    <basicUdiDi>B-07350040630617</basicUdiDi>
    <tradeName>Devyser CFTR 68</tradeName>
    <deviceName>Devyser CFTR 68</deviceName>
    <manufacturerName>Devyser AB</manufacturerName>
    <manufacturerSrn>SE-MF-000001699</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010101</emdnCode>
    <emdnDescription>CYSTIC FIBROSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8-A045-24</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:13:17.977Z</lastUpdated>
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