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    <tradeName>Pipes buffer 100 mL</tradeName>
    <deviceName>Pipes buffer</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR006</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:24.948Z</lastUpdated>
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    <udiDi>05744003280117</udiDi>
    <basicUdiDi>574400328REAGK8U</basicUdiDi>
    <tradeName>05744003280117</tradeName>
    <deviceName>Reagent kit</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA700</reference>
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    <udiDi>05744003280094</udiDi>
    <basicUdiDi>574400328RINSECH</basicUdiDi>
    <tradeName>Detergent for Histareader</tradeName>
    <deviceName>Rinse solutions for Histareader</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA705</reference>
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    <lastUpdated>2026-07-31T09:38:20.951Z</lastUpdated>
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    <tradeName>Release 23SEP2013</tradeName>
    <deviceName>Software</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020282</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v4.0-0613</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:18.547Z</lastUpdated>
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    <udiDi>05744003280025</udiDi>
    <basicUdiDi>574400328READER8M</basicUdiDi>
    <tradeName>Histareader501-1</tradeName>
    <deviceName>Histareader501</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020280</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA501-1</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:16.962Z</lastUpdated>
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    <udiDi>05744003280032</udiDi>
    <basicUdiDi>574400328SOFTWE5</basicUdiDi>
    <tradeName>Release 13AUG2012</tradeName>
    <deviceName>Software</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0201020282</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v3.0-0612</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:32:42.869Z</lastUpdated>
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    <udiDi>05744003280018</udiDi>
    <basicUdiDi>574400328READER8M</basicUdiDi>
    <tradeName>Histareader501</tradeName>
    <deviceName>Histareader501</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020280</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA501</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:32:41.283Z</lastUpdated>
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    <udiDi>05713106000076</udiDi>
    <basicUdiDi>5713106ImmuView_Read23J8</basicUdiDi>
    <tradeName>ImmuView® Reader 2.0</tradeName>
    <deviceName>ImmuView® Reader 2.0</deviceName>
    <manufacturerName>SSI Diagnostica A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000023933</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213414</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:12:02.503Z</lastUpdated>
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    <udiDi>05425030420027</udiDi>
    <basicUdiDi>5425030421024R9</basicUdiDi>
    <tradeName>i-Track 10 Trigger Set</tradeName>
    <deviceName>IDS-iSYS Trigger Set</deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD IS-CT100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:46.529Z</lastUpdated>
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    <udiDi>05425030420010</udiDi>
    <basicUdiDi>5425030421017RC</basicUdiDi>
    <tradeName>i-Track 10 System Liquid</tradeName>
    <deviceName>IDS-iSYS System Liquid (Syst.l)</deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD IS-CS100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:44.833Z</lastUpdated>
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    <udiDi>05425030420003</udiDi>
    <basicUdiDi>5425030421031R6</basicUdiDi>
    <tradeName>i-Track 10 Wash Solution</tradeName>
    <deviceName>IDS-iSYS Wash Solution (Wash S)</deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD IS-CW100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:44.216Z</lastUpdated>
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    <udiDi>05425023685013</udiDi>
    <basicUdiDi>5425023685013VU</basicUdiDi>
    <tradeName>BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software</tradeName>
    <deviceName>BlueScan/DrDot Software</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLUESCAN1 + DR DOT LIC4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:14.249Z</lastUpdated>
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    <udiDi>05425023685006</udiDi>
    <basicUdiDi>5425023685006VX</basicUdiDi>
    <tradeName>BlueDiver Instrument</tradeName>
    <deviceName>BlueDiver Instrument I</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BLUEDIVER1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:02.087Z</lastUpdated>
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    <udiDi>04562185380033</udiDi>
    <basicUdiDi>5430000495000020955MW</basicUdiDi>
    <tradeName>AIA-PACK WASH CONCENTRATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020955</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:57:50.411Z</lastUpdated>
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    <udiDi>04562185380026</udiDi>
    <basicUdiDi>5430000495000020956MY</basicUdiDi>
    <tradeName>AIA-PACK DILUENT CONCENTRATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020956</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:57:49.623Z</lastUpdated>
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    <udiDi>15065023763396</udiDi>
    <basicUdiDi>5065023763TV100VD</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Immunofluorescence Analyzer</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:33.368Z</lastUpdated>
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    <udiDi>05060969430053</udiDi>
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    <tradeName>B20</tradeName>
    <deviceName>B20 (Non-Heated)</deviceName>
    <manufacturerName>Bee Robotics</manufacturerName>
    <manufacturerSrn>GB-MF-000023998</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB20-NH</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:58:15.554Z</lastUpdated>
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    <manufacturerName>Bee Robotics</manufacturerName>
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    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB20-H</reference>
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    <lastUpdated>2026-07-31T05:58:11.555Z</lastUpdated>
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    <tradeName>BeeBlot</tradeName>
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    <manufacturerName>Bee Robotics</manufacturerName>
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    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:58:10.751Z</lastUpdated>
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    <manufacturerName>Bee Robotics</manufacturerName>
    <manufacturerSrn>GB-MF-000023998</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
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    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:58:09.964Z</lastUpdated>
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