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    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:29:23.349Z</lastUpdated>
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    <deviceName>UNION Immune Analyzer</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6104</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:39.388Z</lastUpdated>
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    <udiDi>06925912710431</udiDi>
    <basicUdiDi>692591270141H4</basicUdiDi>
    <tradeName>06925912710431</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020103</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput &gt; 250 and &lt;= 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C6106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:28:39.379Z</lastUpdated>
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    <udiDi>06925794520043</udiDi>
    <basicUdiDi>69257945W0201020104D0KF</basicUdiDi>
    <tradeName>CM-320 Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020104</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013359</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:59.162Z</lastUpdated>
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    <udiDi>06925794520036</udiDi>
    <basicUdiDi>69257945W0201020103D0KA</basicUdiDi>
    <tradeName>CM-320i Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</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 - MODERATE TO HIGH ROUTINE (Throughput &gt; 250 and &lt;= 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3013370</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:41.357Z</lastUpdated>
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    <udiDi>06925794515025</udiDi>
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    <tradeName>CM-180 Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</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 - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3015506</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:27:38.530Z</lastUpdated>
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    <udiDi>06921963722959</udiDi>
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    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>BOSON 3000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:12:03.129Z</lastUpdated>
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    <udiDi>06921807605035</udiDi>
    <basicUdiDi>692180760503F6</basicUdiDi>
    <tradeName>Fluorescence Immunoassay Analyzer LEPU Quant 1600</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer LEPU Quant 1600</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JY20LEPUQuant-Fluo1600</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:11:12.652Z</lastUpdated>
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    <udiDi>06921807601136</udiDi>
    <basicUdiDi>692180760113EM</basicUdiDi>
    <tradeName>Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800</tradeName>
    <deviceName>Colloidal Gold Immunochromatograpic Assay Analyzer LEPU Quant 800</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</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>JY04LEPU Quant 800</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:11:11.851Z</lastUpdated>
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    <udiDi>06921807600726</udiDi>
    <basicUdiDi>692180760072EY</basicUdiDi>
    <tradeName>Fluorescence immunochromatography analyzer LEPU Quant-Fluo800</tradeName>
    <deviceName>Fluorescence immunochromatography analyzer LEPU Quant-Fluo800</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JY05LEPU Quant-Fluo 800</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:11:06.241Z</lastUpdated>
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    <udiDi>06921026705264</udiDi>
    <basicUdiDi>69210267JS800GJ</basicUdiDi>
    <tradeName>06921026705264</tradeName>
    <deviceName>Jet-iStar 800 Analyzer</deviceName>
    <manufacturerName>Joinstar Biomedical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001083</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JS800</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:07:59.347Z</lastUpdated>
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    <udiDi>05905351316679</udiDi>
    <basicUdiDi>5905351316BNA100UY</basicUdiDi>
    <tradeName>TestiQ</tradeName>
    <deviceName>Rapid Test Analyzer</deviceName>
    <manufacturerName>Bio-Novum Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000048483</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BNA-100</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:02:12.948Z</lastUpdated>
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    <tradeName>Lysis reagent (HClO4 - 7%), 10 mL</tradeName>
    <deviceName>Lysis reagent</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA704</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:49.557Z</lastUpdated>
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    <tradeName>IL-3, 0,1 µg</tradeName>
    <deviceName>IL-3</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR004</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:48.776Z</lastUpdated>
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    <basicUdiDi>574400328STOPFW</basicUdiDi>
    <tradeName>Stop reagent (HClO4), 100 mL</tradeName>
    <deviceName>Stop reagent (HClO4)</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T09:38:48.345Z</lastUpdated>
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    <tradeName>Stripping buffer, 100 mL</tradeName>
    <deviceName>Stripping buffer</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA701</reference>
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    <lastUpdated>2026-07-31T09:38:43.546Z</lastUpdated>
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    <tradeName>Diluent (NaOH), 10 mL</tradeName>
    <deviceName>Diluent (NaOH)</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
    <manufacturerSrn>DK-MF-000021844</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLR009</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:29.760Z</lastUpdated>
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    <tradeName>OPA Disc 25 mg, 20 pcs</tradeName>
    <deviceName>OPA Discs</deviceName>
    <manufacturerName>RefLab Aps</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RLA708</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:38:27.361Z</lastUpdated>
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    <tradeName>Wash buffer 200 mL</tradeName>
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    <manufacturerName>RefLab Aps</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T09:38:25.754Z</lastUpdated>
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