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    <tradeName>ANA Screen FIA Kit</tradeName>
    <deviceName>ANA Screen FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0054</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:13:58.802Z</lastUpdated>
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    <udiDi>04250289512633</udiDi>
    <basicUdiDi>B-04250289512633</basicUdiDi>
    <tradeName>AESKUSLIDES® ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.181.BULK5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:58.132Z</lastUpdated>
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    <udiDi>04250289512626</udiDi>
    <basicUdiDi>B-04250289512626</basicUdiDi>
    <tradeName>AESKUSLIDES® ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.180.BULK5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:55.741Z</lastUpdated>
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    <udiDi>04250289512619</udiDi>
    <basicUdiDi>B-04250289512619</basicUdiDi>
    <tradeName>AESKUSLIDES® ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:54.153Z</lastUpdated>
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    <udiDi>04250289512602</udiDi>
    <basicUdiDi>B-04250289512602</basicUdiDi>
    <tradeName>AESKUSLIDES® ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.180</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:53.347Z</lastUpdated>
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    <udiDi>04250289504997</udiDi>
    <basicUdiDi>B-04250289504997</basicUdiDi>
    <tradeName>AESKUBLOTS® ANA-17 comp</tradeName>
    <deviceName>AESKUBLOTS® ANA-17 comp</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:25.244Z</lastUpdated>
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    <udiDi>04250289504744</udiDi>
    <basicUdiDi>B-04250289504744</basicUdiDi>
    <tradeName>AESKUSLIDES® ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.101.BULK5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:19.655Z</lastUpdated>
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    <udiDi>04250289504720</udiDi>
    <basicUdiDi>B-04250289504720</basicUdiDi>
    <tradeName>AESKUSLIDES® ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:18.855Z</lastUpdated>
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    <udiDi>04250289504515</udiDi>
    <basicUdiDi>B-04250289504515</basicUdiDi>
    <tradeName>AESKUBLOTS® ANA-17 Pro</tradeName>
    <deviceName>AESKUBLOTS® ANA-17 Pro</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:07.640Z</lastUpdated>
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    <udiDi>04250289503860</udiDi>
    <basicUdiDi>B-04250289503860</basicUdiDi>
    <tradeName>AESKUSLIDES®  ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.100.BULK5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:06.829Z</lastUpdated>
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    <udiDi>04250289500005</udiDi>
    <basicUdiDi>B-04250289500005</basicUdiDi>
    <tradeName>AESKUSLIDES® ANA HEp-2</tradeName>
    <deviceName>AESKUSLIDES® ANA HEp-2</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51.100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:00.440Z</lastUpdated>
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    <udiDi>04049325004450</udiDi>
    <basicUdiDi>B-04049325004450</basicUdiDi>
    <tradeName>ANA Screen 8 ELISA</tradeName>
    <deviceName>ANA Screen 8 ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE75421</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:09:57.406Z</lastUpdated>
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  <row>
    <udiDi>04049325004436</udiDi>
    <basicUdiDi>B-04049325004436</basicUdiDi>
    <tradeName>ANA Profile 8 ELISA</tradeName>
    <deviceName>ANA Profile 8 ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE75401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:09:52.602Z</lastUpdated>
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    <udiDi>04049325003750</udiDi>
    <basicUdiDi>B-04049325003750</basicUdiDi>
    <tradeName>ANA Hep-2 Screen ELISA</tradeName>
    <deviceName>ANA Hep-2 Screen ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE70151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:09:07.737Z</lastUpdated>
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    <udiDi>D-0056E</udiDi>
    <basicUdiDi>B-0056E</basicUdiDi>
    <tradeName>D-0056E</tradeName>
    <deviceName>EasyMagPlex ANA Kit</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:56:15.319Z</lastUpdated>
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    <udiDi>08809446480627</udiDi>
    <basicUdiDi>880944648ANP01JK</basicUdiDi>
    <tradeName>PROTIA ANA Profile</tradeName>
    <deviceName>PROTIA ANA Profile</deviceName>
    <manufacturerName>PROTIA Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026040</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PANP0112</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:20.110Z</lastUpdated>
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    <udiDi>48058945154692</udiDi>
    <basicUdiDi>8058945153AX4020ANAWC</basicUdiDi>
    <tradeName>Evo Autoimmune SPA</tradeName>
    <deviceName>Autoimmunity SPA ANA Screen - Autoimmunità SPA ANA Screen</deviceName>
    <manufacturerName>ABD SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000029729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3AX4020 ANA</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:46.160Z</lastUpdated>
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    <udiDi>08034049110996</udiDi>
    <basicUdiDi>8034049110996WB</basicUdiDi>
    <tradeName>08034049110996</tradeName>
    <deviceName>ANA Screen</deviceName>
    <manufacturerName>Dia.Metra Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027206</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKO099</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:24:57.822Z</lastUpdated>
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    <tradeName>CHORUS ANA-SCREEN</tradeName>
    <deviceName>CHORUS ANA-SCREEN</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86014</reference>
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    <lastUpdated>2026-07-03T05:15:19.510Z</lastUpdated>
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    <tradeName>CHORUS ANA-8</tradeName>
    <deviceName>CHORUS ANA-8</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:15:18.747Z</lastUpdated>
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