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    <tradeName>STart Max</tradeName>
    <deviceName>Semi-automatic Analyzer</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
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    <basicUdiDi>08619000003PT2PROUU</basicUdiDi>
    <tradeName>Coag-Sense Prothrombin Time (PT)/INR Monitoring System Professional Use</tradeName>
    <deviceName>Coag-Sense Prothrombin Time (PT)/INR Monitoring System Professional Use</deviceName>
    <manufacturerName>CoaguSense Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026989</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>03P70-02</reference>
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    <tradeName>GEM® Hemochron™ 100 System</tradeName>
    <deviceName>GEM® Hemochron™ 100 System</deviceName>
    <manufacturerName>Accriva Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009902</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000GH100</reference>
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    <basicUdiDi>0711234510035MA</basicUdiDi>
    <tradeName>Hemochron™ Whole Blood Microcoagulation System</tradeName>
    <deviceName>Hemochron™ Whole Blood Microcoagulation System - Hemochron Signature Elite Instrument (International)</deviceName>
    <manufacturerName>Accriva Diagnostics, Inc.</manufacturerName>
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    <manufacturerName>Accriva Diagnostics, Inc.</manufacturerName>
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    <tradeName>Hemochron™</tradeName>
    <deviceName>Hemochron™ Report Maker</deviceName>
    <manufacturerName>Accriva Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009902</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>COAGULOMETERS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPM-CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:53:23.842Z</lastUpdated>
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    <basicUdiDi>0711234510011LU</basicUdiDi>
    <tradeName>Hemochron™ Signature Elite</tradeName>
    <deviceName>Hemochron™ Signature Elite</deviceName>
    <manufacturerName>Accriva Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009902</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202020101</emdnCode>
    <emdnDescription>SEMI-AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELITE</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:53:06.008Z</lastUpdated>
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    <basicUdiDi>0405686902119VB</basicUdiDi>
    <tradeName>BFT II Analyzer</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>
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    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446541</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:25:35.409Z</lastUpdated>
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    <tradeName>09120036863293</tradeName>
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    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0202020185</emdnCode>
    <emdnDescription>COAGULOMETERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9820328</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:57.269Z</lastUpdated>
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    <tradeName>Ceveron t100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0202020102</emdnCode>
    <emdnDescription>AUTOMATED COAGULOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9822110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:26:56.883Z</lastUpdated>
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    <tradeName>Ceveron s100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0202020102</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>9822210</reference>
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    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
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