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    <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>
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    <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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    <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>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>
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    <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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    <tradeName>Carbon Dioxide (CO2) Kit (Enzymic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060601</emdnCode>
    <emdnDescription>CARBON DIOXIDE - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002190-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:58.255Z</lastUpdated>
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    <udiDi>06944904037684</udiDi>
    <basicUdiDi>69449040004ECO2********LD</basicUdiDi>
    <tradeName>Carbon Dioxide (CO2) Kit (Enzymic Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060601</emdnCode>
    <emdnDescription>CARBON DIOXIDE - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002191-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:58.219Z</lastUpdated>
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    <tradeName>MAXLYTE</tradeName>
    <deviceName>Maxlyte pH Electrode</deviceName>
    <manufacturerName>Avecon Healthcare Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000040691</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060602</emdnCode>
    <emdnDescription>PH - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVMEPH-1</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:50:45.249Z</lastUpdated>
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    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 Cartridge</tradeName>
    <deviceName>CarePak 110 Cartridge</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-50T2W</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:07.498Z</lastUpdated>
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    <basicUdiDi>8806712POCBGCT00123</basicUdiDi>
    <tradeName>i-Smart 300 Cartridge</tradeName>
    <deviceName>i-Smart 300 Cartridge</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT001-30T2W</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:05.892Z</lastUpdated>
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    <udiDi>08806712906249</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 Cartridge</tradeName>
    <deviceName>CarePak 108 Cartridge</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-50T3W</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:44:05.087Z</lastUpdated>
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    <udiDi>06978896414635</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06978896414635</tradeName>
    <deviceName>Blood Gas Testing Cartridge</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-PT3-2-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:02:16.917Z</lastUpdated>
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    <udiDi>06972873821508</udiDi>
    <basicUdiDi>697287382ISEWU</basicUdiDi>
    <tradeName>06972873821508</tradeName>
    <deviceName>Refill Solution</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060606</emdnCode>
    <emdnDescription>BLOOD GAS BUFFERS AND SOLUTIONS - ELECTRODES OR CASSETTE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:19:21.988Z</lastUpdated>
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    <tradeName>Refill solution</tradeName>
    <deviceName>Refill Solution</deviceName>
    <manufacturerName>Shenzhen Cornley Bio-Medical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017322</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060606</emdnCode>
    <emdnDescription>BLOOD GAS BUFFERS AND SOLUTIONS - ELECTRODES OR CASSETTE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T10:19:15.586Z</lastUpdated>
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    <basicUdiDi>6438153BU00182C2</basicUdiDi>
    <tradeName>pH Micro Volume Electrode</tradeName>
    <deviceName>pH Micro Volume Electrode</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060602</emdnCode>
    <emdnDescription>PH - ELECTRODES (BG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981597</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:06:38.465Z</lastUpdated>
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    <tradeName>i-Smart 300 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT001-30T3W</reference>
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    <lastUpdated>2026-07-01T19:48:25.086Z</lastUpdated>
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    <tradeName>i-Smart 300 Cartridge</tradeName>
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    <manufacturerName>i-SENS, Inc.</manufacturerName>
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    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
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    <tradeName>i-Smart 300 Cartridge</tradeName>
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    <manufacturerName>i-SENS, Inc.</manufacturerName>
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    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
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    <tradeName>i-Smart 300 Cartridge</tradeName>
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    <manufacturerName>i-SENS, Inc.</manufacturerName>
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    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
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    <tradeName>i-Smart 300 Cartridge</tradeName>
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    <manufacturerName>i-SENS, Inc.</manufacturerName>
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    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
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    <reference>POCBGCT001-100T3W</reference>
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    <tradeName>i-Smart 300 Cartridge</tradeName>
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    <manufacturerName>i-SENS, Inc.</manufacturerName>
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    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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