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    <tradeName>blood glucose monitoring system</tradeName>
    <deviceName>blood glucose monitoring system</deviceName>
    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001077</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <tradeName>blood glucose meter</tradeName>
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    <manufacturerName>Cofoe Medical Technology Co.,Ltd.</manufacturerName>
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    <tradeName>Auto Chemiluminescence Analyzer</tradeName>
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    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
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    <tradeName>Elisa Microplate Reader</tradeName>
    <deviceName>Elisa Microplate Reader</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-EL10DA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:43:21.370Z</lastUpdated>
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    <udiDi>06971674860006</udiDi>
    <basicUdiDi>6936895BS00326</basicUdiDi>
    <tradeName>Automatic Chemistry Analyzer</tradeName>
    <deviceName>Automatic Chemistry Analyzer</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:31:09.170Z</lastUpdated>
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    <udiDi>06933289831673</udiDi>
    <basicUdiDi>69332898CE5100F8</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName>Automatic Glycohemoglobin Analyzer</deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050201</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WK02</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:29:54.266Z</lastUpdated>
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    <tradeName>Chemistry Analyzer ACCENT-400</tradeName>
    <deviceName>Chemistry Analyzer</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h &gt; 400 and &lt;= 800)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B08-A0001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:21:15.308Z</lastUpdated>
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    <basicUdiDi>5600717621CARTDRIGE94</basicUdiDi>
    <tradeName>05600717621045</tradeName>
    <deviceName>Labinlight Cartdrige</deviceName>
    <manufacturerName>LABINLIGHT, LDA</manufacturerName>
    <manufacturerSrn>PT-MF-000034199</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H100100</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:01:39.290Z</lastUpdated>
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    <basicUdiDi>69332898CE5100F8</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050201</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WK37</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:58:15.194Z</lastUpdated>
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    <udiDi>04987295657873</udiDi>
    <basicUdiDi>4987295BU002ZT</basicUdiDi>
    <tradeName>HM-JACKarcⅡ</tradeName>
    <deviceName>HM-JACKarcⅡ</deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65787</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:40:34.072Z</lastUpdated>
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    <udiDi>04902520282798</udiDi>
    <basicUdiDi>454741030100000000000436U</basicUdiDi>
    <tradeName>FUJI PLAIN TUBE</tradeName>
    <deviceName>FUJI PLAIN TUBE</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04902520282798</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:53.564Z</lastUpdated>
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    <udiDi>04902520282767</udiDi>
    <basicUdiDi>454741030100000000000426S</basicUdiDi>
    <tradeName>FUJI HEPARIN TUBE</tradeName>
    <deviceName>FUJI HEPARIN TUBE</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04902520282767</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:52.760Z</lastUpdated>
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    <basicUdiDi>4547410301000000000003975</basicUdiDi>
    <tradeName>FUJI DRI-CHEM MIXING CUPS S</tradeName>
    <deviceName>FUJI DRI-CHEM MIXING CUPS</deviceName>
    <manufacturerName>FUJIFILM Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000010401</manufacturerSrn>
    <authorisedRepresentativeName>FUJIFILM Healthcare Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000040920</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04902520282620</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:32:51.176Z</lastUpdated>
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    <udiDi>04712803533789</udiDi>
    <basicUdiDi>4712803534MGCLI120JP</basicUdiDi>
    <tradeName>GBC Chemiluminescence Analyzer (Non-Sterile)</tradeName>
    <deviceName>GBC Chemiluminescence Analyzer (Non-Sterile)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4MGCLI120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:31:23.782Z</lastUpdated>
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    <basicUdiDi>42520204CPLUSAP</basicUdiDi>
    <tradeName>CubePlus</tradeName>
    <deviceName>CubePlus</deviceName>
    <manufacturerName>opTricon GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024656</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CUBE-840-02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:14:40.227Z</lastUpdated>
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    <tradeName>SPINCHIP® SOFTWARE</tradeName>
    <deviceName>SPINCHIP® SOFTWARE</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>425376</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:51:04.070Z</lastUpdated>
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    <tradeName>SpinChip SampleTransfer</tradeName>
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    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-16T04:51:03.268Z</lastUpdated>
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    <tradeName>SPINCHIP Analyzer</tradeName>
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    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>425326</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:51:02.467Z</lastUpdated>
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    <tradeName>FIAPresto  FIAVet</tradeName>
    <deviceName>Time-resolved immunofluorescence analyzer</deviceName>
    <manufacturerName>Bifour Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034957</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020192</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>HTI CL-500</tradeName>
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    <manufacturerName>High Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000036184</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>URINE STRIP READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:52:39.140Z</lastUpdated>
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