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    <tradeName>Granulat do separacji surowicy - 600g</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDLAB-PRODUCTS Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000028388</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W050301029001</emdnCode>
    <emdnDescription>BLOOD COMPONENTS SEPARATORS, PLASTIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-9600-0</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:02:33.899Z</lastUpdated>
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    <udiDi>05905699562813</udiDi>
    <basicUdiDi>5905072235068ZK</basicUdiDi>
    <tradeName>Granulat do separacji surowicy - 1000g</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDLAB-PRODUCTS Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000028388</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W050301029001</emdnCode>
    <emdnDescription>BLOOD COMPONENTS SEPARATORS, PLASTIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-32-91000-0</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T00:02:32.748Z</lastUpdated>
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    <udiDi>08470001685407</udiDi>
    <basicUdiDi>8431785UDI-DI-066R</basicUdiDi>
    <tradeName>COLECTOR ORINA 120 CC. VACIO APOSAN</tradeName>
    <deviceName></deviceName>
    <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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:23.101Z</lastUpdated>
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    <udiDi>08470001696588</udiDi>
    <basicUdiDi>8431785UDI-DI-066R</basicUdiDi>
    <tradeName>COLECTOR ORINA 120 CC. VP PHARMA VAC.</tradeName>
    <deviceName></deviceName>
    <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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76O</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:23.082Z</lastUpdated>
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  <row>
    <udiDi>08470001846907</udiDi>
    <basicUdiDi>8431785UDI-DI-066R</basicUdiDi>
    <tradeName>KIT VACUUM APOSAN</tradeName>
    <deviceName></deviceName>
    <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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:22.897Z</lastUpdated>
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  <row>
    <udiDi>08470001986016</udiDi>
    <basicUdiDi>8431785UDI-DI-076T</basicUdiDi>
    <tradeName>COLECTOR ORINA 24 HORAS VACÍO UNIT. APOSAN</tradeName>
    <deviceName></deviceName>
    <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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:22.756Z</lastUpdated>
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  <row>
    <udiDi>08470002343368</udiDi>
    <basicUdiDi>8431785UDI-DI-086V</basicUdiDi>
    <tradeName>COLECTOR ORINA 24 HORAS UNIT.APOSAN</tradeName>
    <deviceName></deviceName>
    <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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:22.006Z</lastUpdated>
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  <row>
    <udiDi>08470002343443</udiDi>
    <basicUdiDi>8431785UDI-DI-056P</basicUdiDi>
    <tradeName>APOSAN ENVASE ASEPTICO ORINA HECES</tradeName>
    <deviceName></deviceName>
    <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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:40:21.981Z</lastUpdated>
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  <row>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <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-B01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:52.082Z</lastUpdated>
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  <row>
    <udiDi>08809317540580</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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-B02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:52.069Z</lastUpdated>
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  <row>
    <udiDi>08809317540597</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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-F01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:52.057Z</lastUpdated>
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  <row>
    <udiDi>08809317540603</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>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-M01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:52.046Z</lastUpdated>
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  <row>
    <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>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <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>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:51.991Z</lastUpdated>
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  <row>
    <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>
    <emdnCode>W050301029099</emdnCode>
    <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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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DHC-B04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:51.968Z</lastUpdated>
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  <row>
    <udiDi>08809317540696</udiDi>
    <basicUdiDi>880931754C-ChipH5</basicUdiDi>
    <tradeName>C-Chip</tradeName>
    <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>
    <reference>DHC-B0420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:51.956Z</lastUpdated>
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    <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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    <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-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>
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    <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-F0420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:51.933Z</lastUpdated>
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    <udiDi>04987486039082</udiDi>
    <basicUdiDi>4987486BC0108238GZ</basicUdiDi>
    <tradeName>Cuvette (heparin)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108239</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:21.045Z</lastUpdated>
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    <udiDi>04987486039112</udiDi>
    <basicUdiDi>4987486BC0108241GN</basicUdiDi>
    <tradeName>Whole Blood Sample Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108242</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:20.968Z</lastUpdated>
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