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    <basicUdiDi>574400328WASHDP</basicUdiDi>
    <tradeName>Wash buffer 5 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR007W.5</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.710Z</lastUpdated>
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    <udiDi>05744003280179</udiDi>
    <basicUdiDi>574400328WASHDP</basicUdiDi>
    <tradeName>Wash buffer concentrate 10 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR007S.10</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.692Z</lastUpdated>
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    <udiDi>05744003280186</udiDi>
    <basicUdiDi>574400328WASHDP</basicUdiDi>
    <tradeName>Wash buffer concentrate 50 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR007S.50</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.673Z</lastUpdated>
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    <udiDi>05744003280209</udiDi>
    <basicUdiDi>574400328OPAHN</basicUdiDi>
    <tradeName>OPA Disc 25 mg, 100 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA708XL</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.637Z</lastUpdated>
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    <udiDi>05744003280216</udiDi>
    <basicUdiDi>574400328OPAHN</basicUdiDi>
    <tradeName>OPA Disc 5 mg, 10 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR013</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.617Z</lastUpdated>
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  <row>
    <udiDi>05744003280230</udiDi>
    <basicUdiDi>574400328DILUENTGG</basicUdiDi>
    <tradeName>Diluent (NaOH), 1 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA702</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.573Z</lastUpdated>
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  <row>
    <udiDi>05744003280254</udiDi>
    <basicUdiDi>574400328STOPFW</basicUdiDi>
    <tradeName>Stop reagent (HClO4) 1 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA703</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.535Z</lastUpdated>
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  <row>
    <udiDi>05744003280278</udiDi>
    <basicUdiDi>5744003280STRIP6M</basicUdiDi>
    <tradeName>Stripping buffer 1 L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR016</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.491Z</lastUpdated>
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    <udiDi>05744003280308</udiDi>
    <basicUdiDi>5744003280IL34Q</basicUdiDi>
    <tradeName>Preparation Vial (IL-3)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR041</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.425Z</lastUpdated>
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    <udiDi>05744003280315</udiDi>
    <basicUdiDi>5744003280IL34Q</basicUdiDi>
    <tradeName>Preparation Vial (IL-3), Box of 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020285</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA500</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-22T02:14:56.400Z</lastUpdated>
  </row>
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    <udiDi>05055273202694</udiDi>
    <basicUdiDi>50552732AREASGN020F8</basicUdiDi>
    <tradeName>SIGNAL REAGENT – EV701 (REAG SGNL – EV701)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3601</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.876Z</lastUpdated>
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  <row>
    <udiDi>05055273214086</udiDi>
    <basicUdiDi>50552732AREASGN020F8</basicUdiDi>
    <tradeName>SIGNAL REAGENT – EV840 (REAG SGNL – EV840)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3717</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.142Z</lastUpdated>
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  <row>
    <udiDi>05055273214093</udiDi>
    <basicUdiDi>50552732AREASGN020F8</basicUdiDi>
    <tradeName>SIGNAL REAGENT – EV841 (REAG SGNL – EV841)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV3718</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:35:27.126Z</lastUpdated>
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  <row>
    <udiDi>05060169696587</udiDi>
    <basicUdiDi>5060169693968YX</basicUdiDi>
    <tradeName>i-Track10-C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD 810400-C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:44:55.419Z</lastUpdated>
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    <udiDi>05060169696631</udiDi>
    <basicUdiDi>5060169692305X2</basicUdiDi>
    <tradeName>i-Track D-Sorb Solution Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD IS-DS200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:44:55.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060169696648</udiDi>
    <basicUdiDi>5060169693906Y9</basicUdiDi>
    <tradeName>i-Track 10 Immunocleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD IS-IM100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:44:55.333Z</lastUpdated>
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    <udiDi>05060169696679</udiDi>
    <basicUdiDi>5060169692305X2</basicUdiDi>
    <tradeName>Zenit RA D-Sorb Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41436</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:44:55.295Z</lastUpdated>
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    <udiDi>05060169699625</udiDi>
    <basicUdiDi>5060169699625Z8</basicUdiDi>
    <tradeName>IDS-i10T</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-810410</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-21T10:44:55.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>04252020400032</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-755</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.165Z</lastUpdated>
  </row>
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    <udiDi>04252020400063</udiDi>
    <basicUdiDi>42520204CUBEDQ</basicUdiDi>
    <tradeName>Cube Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:05:25.126Z</lastUpdated>
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