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    <deviceName></deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
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    <lastUpdated>2026-07-18T10:57:08.204Z</lastUpdated>
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    <udiDi>06938247231205</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020185</emdnCode>
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    <lastUpdated>2026-07-18T10:57:08.068Z</lastUpdated>
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    <basicUdiDi>69382472Cuvettes-20S6</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:57:08.009Z</lastUpdated>
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    <udiDi>06938247281323</udiDi>
    <basicUdiDi>69382472CleanI-21WC</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8062E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:57:07.855Z</lastUpdated>
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    <udiDi>06938247281378</udiDi>
    <basicUdiDi>69382472Cuvettes-20S6</basicUdiDi>
    <tradeName>06938247281378</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Sun Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027682</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS01E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:57:07.612Z</lastUpdated>
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    <udiDi>06954417600350</udiDi>
    <basicUdiDi>695441762301A1Z3</basicUdiDi>
    <tradeName>Fully Automated Coagulation Analyzer</tradeName>
    <deviceName>Fully Automated Coagulation Analyzer</deviceName>
    <manufacturerName>Shanghai Medconn Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038658</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:48:37.602Z</lastUpdated>
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    <udiDi>06954417600367</udiDi>
    <basicUdiDi>695441762301A1Z3</basicUdiDi>
    <tradeName>Fully Automated Coagulation Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Medconn Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038658</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:32.513Z</lastUpdated>
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    <udiDi>08680952301107</udiDi>
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    <tradeName>OPTO-4 Semi Automated Coagulation Analyser</tradeName>
    <deviceName>OPTO-4 Semi Automated Coagulation Analyser</deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPTO-4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:34:08.223Z</lastUpdated>
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    <udiDi>08680952301091</udiDi>
    <basicUdiDi>8680952301MD-48A</basicUdiDi>
    <tradeName>MD-4 Semi Automated Coagulation Analyser</tradeName>
    <deviceName>MD-4 Semi Automated Coagulation Analyser</deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:34:07.449Z</lastUpdated>
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    <udiDi>08680952301084</udiDi>
    <basicUdiDi>8680952301SF-8000BU</basicUdiDi>
    <tradeName>SF-8000 Automated Coagulation Analyser</tradeName>
    <deviceName>SF-8000 Automated Coagulation Analyser</deviceName>
    <manufacturerName>Sistat Tanı ve Tedavi Sistemleri Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000021882</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF-8000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:34:06.674Z</lastUpdated>
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    <udiDi>06971288640001</udiDi>
    <basicUdiDi>6971288645E6</basicUdiDi>
    <tradeName>06971288640001</tradeName>
    <deviceName>Semi-auto Coagulation Analyzer</deviceName>
    <manufacturerName>Beijing ZONCI Technology Development Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048322</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XL40</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:59:46.147Z</lastUpdated>
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    <udiDi>00842768014444</udiDi>
    <basicUdiDi>0405686902117V7</basicUdiDi>
    <tradeName>BCS System Cuvette Rotors</tradeName>
    <deviceName>IVDR_27_MAR EB_A_BCS_Cuv_Rotor</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446524</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:07.545Z</lastUpdated>
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    <udiDi>00842768012259</udiDi>
    <basicUdiDi>0405686902119VB</basicUdiDi>
    <tradeName>BFT II Analyzer Dispo System</tradeName>
    <deviceName>IVDR_27_MAR EB_A_Cuv_BFT_II</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:02.050Z</lastUpdated>
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    <udiDi>00842768012198</udiDi>
    <basicUdiDi>0405686902105UY</basicUdiDi>
    <tradeName>Behring Coagulation Cup</tradeName>
    <deviceName>IVDR_27_MAR EB_A_Behring_Coag_Cup</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446526</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:01.623Z</lastUpdated>
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    <udiDi>00842768008023</udiDi>
    <basicUdiDi>0405686902118V9</basicUdiDi>
    <tradeName>BC Validation Kit</tradeName>
    <deviceName>IVDR_27_MAR EB_A_BC_Valid_Kit</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:55.530Z</lastUpdated>
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    <udiDi>00842768003752</udiDi>
    <basicUdiDi>0405686902116V5</basicUdiDi>
    <tradeName>Dade PFA Vacuum Cups</tradeName>
    <deviceName>IVDR_27_MAR EB_A_PFA_Vac_Cups</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445703</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:50.924Z</lastUpdated>
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    <basicUdiDi>0405686902115V3</basicUdiDi>
    <tradeName>Dade PFA Priming Cartridges</tradeName>
    <deviceName>IVDR_27_MAR EB_A_PFA_Priming_Cartr</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:50.777Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10458677</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:44.860Z</lastUpdated>
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    <basicUdiDi>0405686900872W4</basicUdiDi>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10488536</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:56.310Z</lastUpdated>
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    <udiDi>00630414002828</udiDi>
    <basicUdiDi>0405686900894WE</basicUdiDi>
    <tradeName>BCS XP System</tradeName>
    <deviceName>IVDR_27_MAR EB_A_INST_BCS_XP</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11240019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:12:23.632Z</lastUpdated>
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