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    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG9-Ⅱ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:26.923Z</lastUpdated>
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    <udiDi>06972337858057</udiDi>
    <basicUdiDi>B-06972337858057</basicUdiDi>
    <tradeName>06972337858057</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG9-Ⅰ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:26.168Z</lastUpdated>
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    <udiDi>06972337858040</udiDi>
    <basicUdiDi>B-06972337858040</basicUdiDi>
    <tradeName>06972337858040</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG8</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:25.398Z</lastUpdated>
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    <udiDi>06972337858033</udiDi>
    <basicUdiDi>B-06972337858033</basicUdiDi>
    <tradeName>06972337858033</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELE-Ⅲ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:21.286Z</lastUpdated>
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    <udiDi>06972337858026</udiDi>
    <basicUdiDi>B-06972337858026</basicUdiDi>
    <tradeName>06972337858026</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELE-Ⅱ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:20.488Z</lastUpdated>
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    <udiDi>06972337858019</udiDi>
    <basicUdiDi>B-06972337858019</basicUdiDi>
    <tradeName>06972337858019</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELE-Ⅰ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:19.684Z</lastUpdated>
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    <udiDi>06972337858002</udiDi>
    <basicUdiDi>B-06972337858002</basicUdiDi>
    <tradeName>06972337858002</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG10-Ⅱ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:19.380Z</lastUpdated>
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    <udiDi>06972337857999</udiDi>
    <basicUdiDi>B-06972337857999</basicUdiDi>
    <tradeName>06972337857999</tradeName>
    <deviceName>i-Check Cartridge</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BG10-Ⅰ</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:14.880Z</lastUpdated>
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    <udiDi>06972337857746</udiDi>
    <basicUdiDi>B-06972337857746</basicUdiDi>
    <tradeName>06972337857746</tradeName>
    <deviceName>Glycated hemoglobin calibrator</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HbA1c</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:14.076Z</lastUpdated>
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    <udiDi>06972337857661</udiDi>
    <basicUdiDi>B-06972337857661</basicUdiDi>
    <tradeName>06972337857661</tradeName>
    <deviceName>CRP and SAA Test Reagent</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 pieces/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:13.282Z</lastUpdated>
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    <udiDi>06972337857654</udiDi>
    <basicUdiDi>B-06972337857654</basicUdiDi>
    <tradeName>06972337857654</tradeName>
    <deviceName>CRP and hs-CRP Test Reagent</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 pieces/box</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:12.481Z</lastUpdated>
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    <udiDi>06972337857401</udiDi>
    <basicUdiDi>B-06972337857401</basicUdiDi>
    <tradeName>06972337857401</tradeName>
    <deviceName>Blood  Gas/Ion/Metabolite Control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060607</emdnCode>
    <emdnDescription>BLOOD GAS CONTROLS -ELECTRODES OR CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQC-hct Level 1:2.0ml×5、Level 2:2.0ml×5、Level 3:2.0ml×5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:08.468Z</lastUpdated>
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    <udiDi>06972337853014</udiDi>
    <basicUdiDi>B-06972337853014</basicUdiDi>
    <tradeName>06972337853014</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202010192</emdnCode>
    <emdnDescription>AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC-8</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:08.302Z</lastUpdated>
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  <row>
    <udiDi>06972337852987</udiDi>
    <basicUdiDi>B-06972337852987</basicUdiDi>
    <tradeName>06972337852987</tradeName>
    <deviceName>Blood Gas/Ion/Metabolite Control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060607</emdnCode>
    <emdnDescription>BLOOD GAS CONTROLS -ELECTRODES OR CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQC Level 1: 2.0ml×5、Level 2: 2.0ml×5、Level 3: 2.0ml×5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:06.886Z</lastUpdated>
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    <udiDi>06972337852482</udiDi>
    <basicUdiDi>B-06972337852482</basicUdiDi>
    <tradeName>06972337852482</tradeName>
    <deviceName>Glycated hemoglobin quality control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HbA1c  Level 1: 0.1ml×1; Level 2: 0.1ml×1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:06.717Z</lastUpdated>
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    <udiDi>06972337850150</udiDi>
    <basicUdiDi>B-06972337850150</basicUdiDi>
    <tradeName>06972337850150</tradeName>
    <deviceName>Electrolyte Control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC-5  low：2.0mL×5、normal：2.0mL×5、high：2.0mL×5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:02.064Z</lastUpdated>
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    <udiDi>06972337850143</udiDi>
    <basicUdiDi>B-06972337850143</basicUdiDi>
    <tradeName>06972337850143</tradeName>
    <deviceName>Electrolyte Calibrator</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060608</emdnCode>
    <emdnDescription>BLOOD GAS CALIBRATORS AND STANDARDS ELECTRODES OR CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QCB-5  low：2.0mL×4、normal：2.0mL×4、high：2.0mL×4.</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:01.267Z</lastUpdated>
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    <udiDi>06972337852222</udiDi>
    <basicUdiDi>697233785i-CheckA012MJ</basicUdiDi>
    <tradeName>06972337852222</tradeName>
    <deviceName>i-Check Blood Gas Analyzer,Handheld</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029099</emdnCode>
    <emdnDescription>VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i-Check</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:43:12.302Z</lastUpdated>
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    <udiDi>06972337851867</udiDi>
    <basicUdiDi>697233785GHgbLyse009BZ</basicUdiDi>
    <tradeName>GHgb-Lyse</tradeName>
    <deviceName>GHgb-Lyse</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60104</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:43:08.297Z</lastUpdated>
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    <udiDi>06972337851836</udiDi>
    <basicUdiDi>697233785Elution001BJ</basicUdiDi>
    <tradeName>Elution Buffer</tradeName>
    <deviceName>Elution Buffer</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:43:07.514Z</lastUpdated>
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