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<eudamedExport entity="devices">
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    <basicUdiDi>47180503600580107Z</basicUdiDi>
    <tradeName>OzTGSO HLA MX11 Typing Kit</tradeName>
    <deviceName>OzTGSO HLA MX11 Typing Kit</deviceName>
    <manufacturerName>TBG Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000029664</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58010, 58011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:34:42.638Z</lastUpdated>
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    <udiDi>04260224890658</udiDi>
    <basicUdiDi>426022489HRTP01ACSC</basicUdiDi>
    <tradeName>04260224890658</tradeName>
    <deviceName>HISTO TYPE Rainbow</deviceName>
    <manufacturerName>BAG Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024383</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>728220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:44:39.055Z</lastUpdated>
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    <udiDi>08436615250097</udiDi>
    <basicUdiDi>843661525GVS-B51N4</basicUdiDi>
    <tradeName>Genvinset® HLA B51</tradeName>
    <deviceName>Genvinset® HLA B51</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-B51-24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:11.705Z</lastUpdated>
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    <udiDi>08436615250103</udiDi>
    <basicUdiDi>843661525GVS-B51N4</basicUdiDi>
    <tradeName>Genvinset® HLA B51 48 test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-B51-48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:37:53.158Z</lastUpdated>
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    <udiDi>+G2860230Z</udiDi>
    <basicUdiDi>++G286LongRangeNGS7K</basicUdiDi>
    <tradeName>H-Seq-LR-NGS Sequenzierungskit für 48 Typisierungen</tradeName>
    <deviceName>H-Seq-LR-NGS 48 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:57.076Z</lastUpdated>
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  <row>
    <udiDi>+G2860140Z</udiDi>
    <basicUdiDi>++G286HSeqNGSP9</basicUdiDi>
    <tradeName>H-Seq-NGS Sequenzierungskit für 7x768 Typisierungen</tradeName>
    <deviceName>H-Seq-NGS Sequenzierungskit für 7x768 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:50.917Z</lastUpdated>
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  <row>
    <udiDi>+G2860010V</udiDi>
    <basicUdiDi>++G286HSeqABCKR</basicUdiDi>
    <tradeName>H-Seq-ABC Sequenzierungskit für 48 Typisierungen</tradeName>
    <deviceName>H-Seq-ABC Sequenzierungskit für 48 Typisierungen</deviceName>
    <manufacturerName>Institut für Klinische Transfusionsmedizin und Immungenetik Ulm gemeinnützige GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018980</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:22:46.086Z</lastUpdated>
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    <udiDi>D-TRMF000028405B51RT50X7</udiDi>
    <basicUdiDi>B-TRMF000028405B51RT50X7</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HLA-B*51 Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B51-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:43.772Z</lastUpdated>
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  <row>
    <udiDi>D-TRMF000028405B27RT50Y2</udiDi>
    <basicUdiDi>B-TRMF000028405B27RT50Y2</basicUdiDi>
    <tradeName>geneMAP</tradeName>
    <deviceName>geneMAP HLA-B*27 Detection Kit, 50T</deviceName>
    <manufacturerName>GENMARK SAĞLIK ÜRÜNLERİ İTHALAT İHRACAT VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000028405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B27-RT50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:20:42.953Z</lastUpdated>
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  <row>
    <udiDi>D-HG01HG</udiDi>
    <basicUdiDi>B-HG01HG</basicUdiDi>
    <tradeName>Cowingene Human Leukocyte Antigen B27 Detection Kit</tradeName>
    <deviceName>Cowingene Human Leukocyte Antigen B27 Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HG01021X, HG01022X, HG01023W</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:54:42.724Z</lastUpdated>
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  <row>
    <udiDi>D-G2MHLA32001JP</udiDi>
    <basicUdiDi>B-G2MHLA32001JP</basicUdiDi>
    <tradeName>HLA Typing NGS Panel</tradeName>
    <deviceName>HLA Typing NGS Panel</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2MHLA32001-ill; G2MHLA32001-MG; G2MHLA32001-TF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:45.217Z</lastUpdated>
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  <row>
    <udiDi>D-G2M801121EL</udiDi>
    <basicUdiDi>B-G2M801121EL</basicUdiDi>
    <tradeName>HLA B27-Q Real Time PCR Kit</tradeName>
    <deviceName>HLA B27-Q Real Time PCR Kit</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M801121, G2M801121R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:44:33.130Z</lastUpdated>
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  <row>
    <udiDi>D-90085-RTFE</udiDi>
    <basicUdiDi>B-90085-RTFE</basicUdiDi>
    <tradeName>D-90085-RTFE</tradeName>
    <deviceName>EliGene® CELIAC DQ PLUS RT</deviceName>
    <manufacturerName>ELISABETH PHARMACON, spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90085-RT</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:36.467Z</lastUpdated>
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  <row>
    <udiDi>D-90071-RTE7</udiDi>
    <basicUdiDi>B-90071-RTE7</basicUdiDi>
    <tradeName>D-90071-RTE7</tradeName>
    <deviceName>EliGene® Coeliac 3.0 RT</deviceName>
    <manufacturerName>ELISABETH PHARMACON, spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90071-RT</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:54:35.122Z</lastUpdated>
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    <udiDi>D-84295773154WTGK</udiDi>
    <basicUdiDi>B-84295773154WTGK</basicUdiDi>
    <tradeName>HLA B27 Strip</tradeName>
    <deviceName>HLA B27 Strip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.154.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:30.941Z</lastUpdated>
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  <row>
    <udiDi>D-84295773152WPFZ</udiDi>
    <basicUdiDi>B-84295773152WPFZ</basicUdiDi>
    <tradeName>CeliacStrip</tradeName>
    <deviceName>CeliacStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.152.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:29.337Z</lastUpdated>
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    <udiDi>08908020139507</udiDi>
    <basicUdiDi>B-08908020139507</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:30:46.286Z</lastUpdated>
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  <row>
    <udiDi>08908007989842</udiDi>
    <basicUdiDi>B-08908007989842</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:08.118Z</lastUpdated>
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    <udiDi>08908007989835</udiDi>
    <basicUdiDi>B-08908007989835</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380020</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:07.310Z</lastUpdated>
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    <basicUdiDi>B-08908007989828</basicUdiDi>
    <tradeName>Truenat HLA-B27</tradeName>
    <deviceName>Truenat HLA-B27</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010401</emdnCode>
    <emdnDescription>HLA-TYPING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>601380005, 601380020, 601380025, 601380050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T18:27:05.722Z</lastUpdated>
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