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    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-405</reference>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-409</reference>
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    <udiDi>06974410140141</udiDi>
    <basicUdiDi>697441014RUA0004HR</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Bioway Biological Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000026464</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-406</reference>
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    <tradeName>Maintenance Wash Buffer A</tradeName>
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    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
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    <tradeName>Wash Buffer 1</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <tradeName>Wash Buffer 2</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
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    <tradeName>Enhancement Reagent 1</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>764032746MOSAIQSYSTEMVQ</basicUdiDi>
    <tradeName>Enhancement Reagent 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-16T05:49:23.460Z</lastUpdated>
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    <basicUdiDi>764032746MOSAIQSYSTEMVQ</basicUdiDi>
    <tradeName>Detection Reagent 1</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>764032746MOSAIQSYSTEMVQ</basicUdiDi>
    <tradeName>Wash Buffer</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155041</reference>
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    <lastUpdated>2026-06-16T05:49:23.417Z</lastUpdated>
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    <tradeName>TMB Substrate</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>155050</reference>
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    <tradeName>IgG Conjugate</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024025</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>IgA Conjugate</tradeName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
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    <manufacturerName>AliveDx Suisse SA</manufacturerName>
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    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Incubation tray for ViraStripe® and ViraBlot tests, 50 channels, white</tradeName>
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    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
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    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Incubation tray for ViraStripe® and ViraBlot tests, 30 channels, black</tradeName>
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    <manufacturerName>Viramed Biotech AG</manufacturerName>
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    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
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    <basicUdiDi>++EVIRIncubationTrayQG</basicUdiDi>
    <tradeName>Incubation tray for ViraStripe® and ViraBlot tests, 30 channels, white</tradeName>
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    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
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