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    <tradeName>CentriDxTM Respiratory Pathogen Panel V</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:43:57.888Z</lastUpdated>
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    <basicUdiDi>B-06973843229416</basicUdiDi>
    <tradeName>CentriDxTM Sexually Transmitted Disease Panel I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-06973843229256</basicUdiDi>
    <tradeName>CentriDxTM Gastrointestinal Pathogen Panel Ⅰ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
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    <basicUdiDi>B-06973843229232</basicUdiDi>
    <tradeName>CentriDxTM Meningitis/Encephalitis Pathogen Panel Ⅰ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ97S1</reference>
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    <basicUdiDi>B-06973843221960</basicUdiDi>
    <tradeName>CentriDxTM Lower Respiratory Pathogen Panel Ⅰ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ62S1</reference>
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    <basicUdiDi>B-06973843221953</basicUdiDi>
    <tradeName>CentriDxTM Tropical Fever Pathogen Panel Ⅰ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSJ96S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>AutoGene 9600 Automatic PCR Analysis System</tradeName>
    <deviceName>AutoGene 9600 Automatic PCR Analysis System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQD-A9600(EA4)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:56.219Z</lastUpdated>
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    <tradeName>LineGene 9600 Pro Fluorescenct Quantitative Detection System</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQD-96A(ED2)</reference>
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    <lastUpdated>2026-07-02T12:04:55.405Z</lastUpdated>
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    <tradeName>careSTART™ Q1 Amplifier</tradeName>
    <deviceName>careSTART™ Q1 Amplifier</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TQA-E00182</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:54.609Z</lastUpdated>
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    <udiDi>06973843221274</udiDi>
    <basicUdiDi>697384322NPA001JY</basicUdiDi>
    <tradeName>GenePure Pro 16H Nucleic Acid Purification System</tradeName>
    <deviceName>GenePure Pro 16H Nucleic Acid Purification System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPA-16H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:50.602Z</lastUpdated>
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    <udiDi>06973843221267</udiDi>
    <basicUdiDi>697384322FQD007H4</basicUdiDi>
    <tradeName>VitroCycler Fluorescent Quantitative Detection System</tradeName>
    <deviceName>VitroCycler Fluorescent Quantitative Detection System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIT-VitroCycler</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:49.802Z</lastUpdated>
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    <udiDi>06973843221205</udiDi>
    <basicUdiDi>697384322NPA005K8</basicUdiDi>
    <tradeName>GenePure Pro 9600 Nucleic Acid Purification System</tradeName>
    <deviceName>GenePure Pro 9600 Nucleic Acid Purification System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NPAm-9600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:49.004Z</lastUpdated>
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    <tradeName>CentriDx Automated Nucleic Acid Analyzer</tradeName>
    <deviceName>CentriDx Automated Nucleic Acid Analyzer</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CentriDx 200(EA4)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:48.203Z</lastUpdated>
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    <tradeName>Bioquant-96m Fluorescent Quantitative Detection System</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <reference>Bioquant-96m</reference>
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    <lastUpdated>2026-07-02T12:04:44.197Z</lastUpdated>
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    <tradeName>LineGene 9600 Plus Fluorescent Quantitative Detection System</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
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    <tradeName>GeneExplorer Thermal Cycler</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE-96G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:42.595Z</lastUpdated>
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    <tradeName>Automated Nucleic Acid Purification and Real Time PCR System</tradeName>
    <deviceName>Automated Nucleic Acid Purification and Real Time PCR System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
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    <tradeName>Automated Nucleic Acid Purification System</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
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    <reference>NPAs-9600</reference>
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    <lastUpdated>2026-07-02T12:04:37.792Z</lastUpdated>
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    <tradeName>GenePure Pro Nucleic Acid Purification System</tradeName>
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    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
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    <reference>NPA-32P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>QuantGene 9600 Fluorescent Quantitative Detection System</tradeName>
    <deviceName>QuantGene 9600 Fluorescent Quantitative Detection System</deviceName>
    <manufacturerName>Hangzhou Bioer Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019512</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQD-96C(EA4)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:36.186Z</lastUpdated>
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