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    <basicUdiDi>69268026HameaT4001MJ</basicUdiDi>
    <tradeName>Haemostasis Analyzer</tradeName>
    <deviceName>Haemostasis Analyzer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Haema T4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:40:55.606Z</lastUpdated>
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    <udiDi>06926802602690</udiDi>
    <basicUdiDi>69268026HameaTX001V7</basicUdiDi>
    <tradeName>Fully-automated Haemostasis Analyzer</tradeName>
    <deviceName>Fully-automated Haemostasis Analyzer</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Haema TX</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:40:38.744Z</lastUpdated>
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    <udiDi>06921807615218</udiDi>
    <basicUdiDi>692180760034EQ</basicUdiDi>
    <tradeName>06921807615218</tradeName>
    <deviceName>Thrombelastography Analyzer</deviceName>
    <manufacturerName>BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000033011</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFMS LEPU-8880</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:11:25.456Z</lastUpdated>
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    <udiDi>04260160470372</udiDi>
    <basicUdiDi>4260160470372RT</basicUdiDi>
    <tradeName>ROTEM® sigma</tradeName>
    <deviceName>ROTEM® sigma</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:25.036Z</lastUpdated>
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    <udiDi>04260160470020</udiDi>
    <basicUdiDi>4260160470020QR</basicUdiDi>
    <tradeName>ROTEM® delta</tradeName>
    <deviceName>ROTEM® delta</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:17.070Z</lastUpdated>
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    <udiDi>06975474516774</udiDi>
    <basicUdiDi>B-06975474516774</basicUdiDi>
    <tradeName>06975474516774</tradeName>
    <deviceName>Thrombelastograph General Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:26.627Z</lastUpdated>
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    <udiDi>06975474516767</udiDi>
    <basicUdiDi>B-06975474516767</basicUdiDi>
    <tradeName>06975474516767</tradeName>
    <deviceName>Thrombelastograph General Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:25.825Z</lastUpdated>
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    <udiDi>06975474516750</udiDi>
    <basicUdiDi>B-06975474516750</basicUdiDi>
    <tradeName>06975474516750</tradeName>
    <deviceName>Thrombelastograph General Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:21.038Z</lastUpdated>
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  <row>
    <udiDi>06975474516743</udiDi>
    <basicUdiDi>B-06975474516743</basicUdiDi>
    <tradeName>06975474516743</tradeName>
    <deviceName>Thrombelastograph General Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5 tests/kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:20.224Z</lastUpdated>
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    <udiDi>06975474516736</udiDi>
    <basicUdiDi>B-06975474516736</basicUdiDi>
    <tradeName>06975474516736</tradeName>
    <deviceName>Thrombelastograph General Cup Kit</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:19.443Z</lastUpdated>
  </row>
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    <udiDi>06976033400022</udiDi>
    <basicUdiDi>697603340TE003CT</basicUdiDi>
    <tradeName>High Throughput Automated Hemostasis Analyzer system</tradeName>
    <deviceName>High Throughput Automated Hemostasis Analyzer System</deviceName>
    <manufacturerName>Render Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032470</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:44.759Z</lastUpdated>
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    <udiDi>06976033400015</udiDi>
    <basicUdiDi>697603340TE002CR</basicUdiDi>
    <tradeName>Hemostasis Analyzer System</tradeName>
    <deviceName>Hemostasis Analyzer System</deviceName>
    <manufacturerName>Render Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032470</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:43.936Z</lastUpdated>
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    <udiDi>06976033400008</udiDi>
    <basicUdiDi>697603340TE001CP</basicUdiDi>
    <tradeName>Hemostasis Analyzer System</tradeName>
    <deviceName>Hemostasis Analyzer System</deviceName>
    <manufacturerName>Render Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032470</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:34:39.134Z</lastUpdated>
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    <udiDi>06975474519652</udiDi>
    <basicUdiDi>697547451WTST-10005U</basicUdiDi>
    <tradeName>06975474519652</tradeName>
    <deviceName>Thrombelastograph Hemostasis Analyzer</deviceName>
    <manufacturerName>Pro-med (Beijing) Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027394</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-1000</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:06:41.656Z</lastUpdated>
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    <udiDi>06926802602706</udiDi>
    <basicUdiDi>69268026HameaTX001V7</basicUdiDi>
    <tradeName>Fully-automated Haemostasis Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Haema TA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:34:11.774Z</lastUpdated>
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    <udiDi>06926802602836</udiDi>
    <basicUdiDi>69268026HameaT4001MJ</basicUdiDi>
    <tradeName>Haemostasis Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Haema T4S</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:34:11.618Z</lastUpdated>
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