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    <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>
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    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B248</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.258Z</lastUpdated>
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    <udiDi>08906213930498</udiDi>
    <basicUdiDi>89080153043B1301KP</basicUdiDi>
    <tradeName>TRUPCR® Factor V Leiden Mutation (G1691A) 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>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1301</reference>
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    <lastUpdated>2026-06-27T19:47:59.218Z</lastUpdated>
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    <udiDi>08906213930504</udiDi>
    <basicUdiDi>89080153043B1301KP</basicUdiDi>
    <tradeName>TRUPCR® Factor V Leiden Mutation (G1691A) Detection Kit</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>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1302</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.196Z</lastUpdated>
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    <udiDi>08906213930528</udiDi>
    <basicUdiDi>89080153043B1321KV</basicUdiDi>
    <tradeName>TRUPCR® Factor II Prothrombin Mutation (G20210A) 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>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1321</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.165Z</lastUpdated>
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    <udiDi>08906213930535</udiDi>
    <basicUdiDi>89080153043B1321KV</basicUdiDi>
    <tradeName>TRUPCR® Factor II Prothrombin Mutation (G20210A) 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>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010103</emdnCode>
    <emdnDescription>FACTOR V LEIDEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1322</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.141Z</lastUpdated>
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    <udiDi>08906213930559</udiDi>
    <basicUdiDi>89080153043B1331KY</basicUdiDi>
    <tradeName>TRUPCR® MTHFR Mutation 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>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1331</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.106Z</lastUpdated>
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    <udiDi>08906213930566</udiDi>
    <basicUdiDi>89080153043B1331KY</basicUdiDi>
    <tradeName>TRUPCR® MTHFR Mutation 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>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T19:47:59.079Z</lastUpdated>
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    <udiDi>06430079584004</udiDi>
    <basicUdiDi>B-06430079584004</basicUdiDi>
    <tradeName>Blueprint Genetics Sanger Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAN-400</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:20.746Z</lastUpdated>
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    <udiDi>06430079583007</udiDi>
    <basicUdiDi>B-06430079583007</basicUdiDi>
    <tradeName>Blueprint Genetics dPCR Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPC-300</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:18.358Z</lastUpdated>
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    <udiDi>06430079581089</udiDi>
    <basicUdiDi>B-06430079581089</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Variant Seq + mtDNA Variant Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-108</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:17.149Z</lastUpdated>
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    <udiDi>06430079581072</udiDi>
    <basicUdiDi>B-06430079581072</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Variant Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-107</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:15.946Z</lastUpdated>
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    <udiDi>06430079581065</udiDi>
    <basicUdiDi>B-06430079581065</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Other Family Seq + mtDNA Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-106</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:13.553Z</lastUpdated>
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  <row>
    <udiDi>06430079581058</udiDi>
    <basicUdiDi>B-06430079581058</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Family Seq + mtDNA Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-105</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:12.337Z</lastUpdated>
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  <row>
    <udiDi>06430079581041</udiDi>
    <basicUdiDi>B-06430079581041</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Proband + mtDNA Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-104</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:09.933Z</lastUpdated>
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    <udiDi>06430079581034</udiDi>
    <basicUdiDi>B-06430079581034</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Other Family Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-103</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:08.735Z</lastUpdated>
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    <udiDi>06430079581027</udiDi>
    <basicUdiDi>B-06430079581027</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Family Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-102</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:06.335Z</lastUpdated>
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    <udiDi>06430079581010</udiDi>
    <basicUdiDi>B-06430079581010</basicUdiDi>
    <tradeName>Blueprint Genetics WES Platform – Proband Seq</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blueprint Genetics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000009837</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WES-101</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:01:05.151Z</lastUpdated>
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    <udiDi>05060654860332</udiDi>
    <basicUdiDi>B-05060654860332</basicUdiDi>
    <tradeName>Genedrive® MT-RNR1 Negative Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNR1-CTRL-03</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:38.216Z</lastUpdated>
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    <basicUdiDi>B-05060654860325</basicUdiDi>
    <tradeName>Genedrive® MT-RNR1 Positive Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNR1-CTRL-02</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:37.319Z</lastUpdated>
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    <basicUdiDi>B-05060654860226</basicUdiDi>
    <tradeName>Genedrive® MT-RNR1 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNR1-CTRL-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:36.412Z</lastUpdated>
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