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    <manufacturerName>ENVASES FARMACÉUTICOS, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000902</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-06-25T23:40:22.897Z</lastUpdated>
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    <basicUdiDi>8431785UDI-DI-076T</basicUdiDi>
    <tradeName>COLECTOR ORINA 24 HORAS VACÍO UNIT. APOSAN</tradeName>
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    <manufacturerName>ENVASES FARMACÉUTICOS, S.A.</manufacturerName>
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    <basicUdiDi>8431785UDI-DI-086V</basicUdiDi>
    <tradeName>COLECTOR ORINA 24 HORAS UNIT.APOSAN</tradeName>
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    <manufacturerName>ENVASES FARMACÉUTICOS, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000902</manufacturerSrn>
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    <basicUdiDi>8431785UDI-DI-056P</basicUdiDi>
    <tradeName>APOSAN ENVASE ASEPTICO ORINA HECES</tradeName>
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    <manufacturerName>ENVASES FARMACÉUTICOS, S.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <udiDi>08809317540573</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>08809317540580</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
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    <reference>DHC-B02</reference>
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  <row>
    <udiDi>08809317540597</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>08809317540603</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
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    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-M01</reference>
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    <lastUpdated>2026-06-25T23:30:52.046Z</lastUpdated>
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    <udiDi>08809317540665</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-N04</reference>
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    <lastUpdated>2026-06-25T23:30:51.991Z</lastUpdated>
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    <udiDi>08809317540672</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-N0420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:51.979Z</lastUpdated>
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  <row>
    <udiDi>08809317540689</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-B04</reference>
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    <lastUpdated>2026-06-25T23:30:51.968Z</lastUpdated>
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    <udiDi>08809317540696</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
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    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-B0420</reference>
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    <lastUpdated>2026-06-25T23:30:51.956Z</lastUpdated>
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  <row>
    <udiDi>08809317540702</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-F04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:51.946Z</lastUpdated>
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    <udiDi>08809317540719</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-F0420</reference>
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    <lastUpdated>2026-06-25T23:30:51.933Z</lastUpdated>
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    <udiDi>04987486039082</udiDi>
    <basicUdiDi>4987486BC0108238GZ</basicUdiDi>
    <tradeName>Cuvette (heparin)</tradeName>
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    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
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    <reference>108239</reference>
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    <lastUpdated>2026-06-22T12:16:21.045Z</lastUpdated>
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    <tradeName>Whole Blood Sample Tube</tradeName>
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    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
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    <reference>108242</reference>
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    <tradeName>STA® - mini Reducer</tradeName>
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    <manufacturerName>Diagnostica Stago</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
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    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
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