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    <tradeName>CHIWELL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059017</emdnCode>
    <emdnDescription>CASSETTE / SLIDE PRINTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-1000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:01:45.631Z</lastUpdated>
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    <tradeName>CHIWELL</tradeName>
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    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059017</emdnCode>
    <emdnDescription>CASSETTE / SLIDE PRINTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-1200</reference>
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    <tradeName>CHIWELL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CASSETTE / SLIDE PRINTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-1600</reference>
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    <lastUpdated>2026-06-28T06:01:45.577Z</lastUpdated>
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    <tradeName>CHIWELL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Chiwell Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000034310</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059017</emdnCode>
    <emdnDescription>CASSETTE / SLIDE PRINTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE-1800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:01:45.541Z</lastUpdated>
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    <udiDi>06948500937591</udiDi>
    <basicUdiDi>69485009LBP008N2</basicUdiDi>
    <tradeName>06948500937591</tradeName>
    <deviceName>Digital Slide Scanner for Pathology</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059099</emdnCode>
    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBL200  ：CCP.000140</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:02.822Z</lastUpdated>
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    <udiDi>06948500937584</udiDi>
    <basicUdiDi>69485009LBP012MR</basicUdiDi>
    <tradeName>06948500937584</tradeName>
    <deviceName>LBP Auto-Coverslipper</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059099</emdnCode>
    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCP.000139</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:01.621Z</lastUpdated>
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    <tradeName>06948500937577</tradeName>
    <deviceName>LBP NovaPrime SD 90 Slide Processor</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCP.000138</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:12:00.456Z</lastUpdated>
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    <tradeName>06948500936747</tradeName>
    <deviceName>LBP NovaPrime MB 64 Slide Processor</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059099</emdnCode>
    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCP.000134</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:10:49.579Z</lastUpdated>
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    <udiDi>06948500936273</udiDi>
    <basicUdiDi>69485009LBP008N2</basicUdiDi>
    <tradeName>06948500936273</tradeName>
    <deviceName>Digital Slide Scanner for Pathology</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059099</emdnCode>
    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCP.082</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:10:41.171Z</lastUpdated>
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    <udiDi>06948500936266</udiDi>
    <basicUdiDi>69485009LBP008N2</basicUdiDi>
    <tradeName>06948500936266</tradeName>
    <deviceName>Digital Slide Scanner for Pathology</deviceName>
    <manufacturerName>Guangzhou LBP Medicine Science &amp; Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026786</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059099</emdnCode>
    <emdnDescription>VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCP.081</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:10:39.975Z</lastUpdated>
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    <udiDi>06947024409980</udiDi>
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    <tradeName>Microplate Washer</tradeName>
    <deviceName>Microplate Washer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059001</emdnCode>
    <emdnDescription>IMMUNOHISTOCHEMISTRY PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-3000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:57:45.329Z</lastUpdated>
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    <udiDi>06947024409621</udiDi>
    <basicUdiDi>69470244014105A</basicUdiDi>
    <tradeName>Microplate Washer</tradeName>
    <deviceName>Microplate Washer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059001</emdnCode>
    <emdnDescription>IMMUNOHISTOCHEMISTRY PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-3500</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:57:16.217Z</lastUpdated>
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    <tradeName>Microplate Washer</tradeName>
    <deviceName>Microplate Washer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IMMUNOHISTOCHEMISTRY PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-3100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:57:15.280Z</lastUpdated>
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    <tradeName>Microplate Washer</tradeName>
    <deviceName>Microplate Washer</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IMMUNOHISTOCHEMISTRY PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RT-2600C</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T21:57:13.815Z</lastUpdated>
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    <tradeName>Fully Automatic IHC Stainer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:15:13.282Z</lastUpdated>
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    <tradeName>Basket Spaced</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>TISSUE PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S45.4505</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:56:37.445Z</lastUpdated>
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    <tradeName>High Capacity Basket (with dividers)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S45.4506</reference>
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    <lastUpdated>2026-06-26T19:56:36.959Z</lastUpdated>
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    <tradeName>HistoCore I-Scan Kit</tradeName>
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    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
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    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S45.4507</reference>
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    <lastUpdated>2026-06-26T19:56:36.605Z</lastUpdated>
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    <tradeName>HistoCore PELORIS 3 Barcode Scanner Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059010</emdnCode>
    <emdnDescription>TISSUE PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S45.4508</reference>
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    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059010</emdnCode>
    <emdnDescription>TISSUE PROCESSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B45.5120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:56:36.103Z</lastUpdated>
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