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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>06970293020266</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:09.499Z</lastUpdated>
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    <deviceName>Buffer</deviceName>
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    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:47:07.120Z</lastUpdated>
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    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293020235</reference>
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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>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293020211</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:58.555Z</lastUpdated>
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    <udiDi>06970293020136</udiDi>
    <basicUdiDi>697029302lytic0013N</basicUdiDi>
    <tradeName>06970293020136</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>06970293020136</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:57.346Z</lastUpdated>
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    <udiDi>06970293020198</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>06970293020198</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:51.345Z</lastUpdated>
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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>
    <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>06970293020181</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:50.159Z</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>
    <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>06970293020174</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:46.648Z</lastUpdated>
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    <udiDi>06970293020167</udiDi>
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    <tradeName>06970293020167</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>06970293020167</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:46.534Z</lastUpdated>
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    <udiDi>06970293020068</udiDi>
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    <tradeName>06970293020068</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>06970293020068</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:42.493Z</lastUpdated>
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    <udiDi>06970293020143</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>06970293020143</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:38.894Z</lastUpdated>
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    <udiDi>06970293020129</udiDi>
    <basicUdiDi>697029302buffer001R7</basicUdiDi>
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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>06970293020129</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:37.596Z</lastUpdated>
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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>
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    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293020075</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:27.439Z</lastUpdated>
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    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032274</manufacturerSrn>
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    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293020105</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:26.283Z</lastUpdated>
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    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
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    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293020099</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T21:46:22.644Z</lastUpdated>
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    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>06970293020082</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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    <deviceName>HEMATOLOGY ANALYSIS LYTIC AGENT</deviceName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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    <deviceName>Buffer</deviceName>
    <manufacturerName>Zhejiang xinke Medical Technology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
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