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    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293021904</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021904</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:54.551Z</lastUpdated>
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    <udiDi>06970293021898</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293021898</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021898</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:53.352Z</lastUpdated>
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    <udiDi>06970293021881</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293021881</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021881</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:52.154Z</lastUpdated>
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    <udiDi>06970293021874</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293021874</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021874</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:50.955Z</lastUpdated>
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    <udiDi>06970293021850</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293021850</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021850</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:44.940Z</lastUpdated>
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    <udiDi>06970293021843</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293021843</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021843</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:43.742Z</lastUpdated>
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    <udiDi>06970293021836</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293021836</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021836</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:42.544Z</lastUpdated>
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    <udiDi>06970293021829</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293021829</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021829</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:41.342Z</lastUpdated>
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    <udiDi>06970293021812</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293021812</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021812</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:35.337Z</lastUpdated>
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    <udiDi>06970293021805</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293021805</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021805</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:34.134Z</lastUpdated>
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    <udiDi>06970293021799</udiDi>
    <basicUdiDi>697029302diluent001DG</basicUdiDi>
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    <deviceName>HEMATOLOGY ANALYSIS DILUENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021799</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:32.934Z</lastUpdated>
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    <udiDi>06970293021775</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293021775</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021775</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:31.739Z</lastUpdated>
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    <udiDi>06970293021768</udiDi>
    <basicUdiDi>697029302clean001GV</basicUdiDi>
    <tradeName>06970293021768</tradeName>
    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021768</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:25.735Z</lastUpdated>
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    <udiDi>06970293021744</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
    <tradeName>06970293021744</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021744</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:24.534Z</lastUpdated>
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    <udiDi>06970293021737</udiDi>
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    <deviceName>HEMATOLOGY ANALYSIS DILUENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021737</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:23.333Z</lastUpdated>
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    <udiDi>06970293021720</udiDi>
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    <deviceName>CLEANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021720</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:22.130Z</lastUpdated>
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    <udiDi>06970293021690</udiDi>
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    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021690</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:16.134Z</lastUpdated>
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    <deviceName>HEMATOLOGY ANALYSIS STANING SOLUTION</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021676</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:14.916Z</lastUpdated>
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    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021669</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:13.715Z</lastUpdated>
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    <tradeName>06970293021652</tradeName>
    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293021652</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:52:12.519Z</lastUpdated>
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