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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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT001-300T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:16.786Z</lastUpdated>
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    <udiDi>08806712906256</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 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>
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    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-100T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.931Z</lastUpdated>
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    <udiDi>08806712906263</udiDi>
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    <tradeName>CarePak 108 Cartridge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <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>POCBGCT004-200T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.493Z</lastUpdated>
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    <udiDi>08806712906270</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-200T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.370Z</lastUpdated>
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    <udiDi>08806712906287</udiDi>
    <basicUdiDi>8806712POCBGCT00429</basicUdiDi>
    <tradeName>CarePak 108 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT004-300T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:15.110Z</lastUpdated>
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  <row>
    <udiDi>08806712906300</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-50T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:09.892Z</lastUpdated>
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  <row>
    <udiDi>08806712906317</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-100T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:07.837Z</lastUpdated>
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    <udiDi>08806712906324</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-100T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:04.140Z</lastUpdated>
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    <udiDi>08806712906331</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-200T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:03.730Z</lastUpdated>
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    <udiDi>08806712906348</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-200T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:03.015Z</lastUpdated>
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    <udiDi>08806712906355</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-300T2W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:02.497Z</lastUpdated>
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  <row>
    <udiDi>08806712906362</udiDi>
    <basicUdiDi>8806712POCBGCT0052B</basicUdiDi>
    <tradeName>CarePak 110 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>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCBGCT005-300T3W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:48:02.013Z</lastUpdated>
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  <row>
    <udiDi>06973720135083</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06973720135083</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-PT3-120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:44.927Z</lastUpdated>
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    <udiDi>06973720135076</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06973720135076</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-PT3-60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:43.743Z</lastUpdated>
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    <udiDi>06973720135069</udiDi>
    <basicUdiDi>697372013BGBG001B4</basicUdiDi>
    <tradeName>06973720135069</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-PT3-25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:06:37.765Z</lastUpdated>
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    <udiDi>06933289829991</udiDi>
    <basicUdiDi>B-06933289829991</basicUdiDi>
    <tradeName>06933289829991</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W795P0002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:07:05.488Z</lastUpdated>
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    <udiDi>06933289829984</udiDi>
    <basicUdiDi>B-06933289829984</basicUdiDi>
    <tradeName>06933289829984</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W795P0001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:07:04.276Z</lastUpdated>
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    <udiDi>06933289804288</udiDi>
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    <tradeName>06933289804288</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060610</emdnCode>
    <emdnDescription>BLOOD GAS INCL. ELECTROLYTES / METABOLITES - MULTI USE CASSETTE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W459-C7P4-E, W461-C7P4-E, W465-C7P4-E, W466-C7P4-E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:05:11.415Z</lastUpdated>
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