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    <tradeName>Uni-medica</tradeName>
    <deviceName>Nucleic Acid Extractor</deviceName>
    <manufacturerName>Shenzhen Uni-medica Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022946</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>15.09.002.02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:28:59.261Z</lastUpdated>
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    <tradeName>06974541565035</tradeName>
    <deviceName>Automated Nucleic Acid Extraction System</deviceName>
    <manufacturerName>BioTeke Corporation（Wuxi）Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007517</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>AU1001</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:28:08.737Z</lastUpdated>
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    <udiDi>06974454727308</udiDi>
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    <tradeName>06974454727308</tradeName>
    <deviceName>Automatic Nucleic Acid Extractor</deviceName>
    <manufacturerName>Jiangsu CoWin Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008981</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CWX901</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:10:02.496Z</lastUpdated>
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    <udiDi>06974323018025</udiDi>
    <basicUdiDi>697432301YQ002FF</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction and Real-Time PCR System</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction and Real-Time PCR System</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</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>MP112401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:54:35.548Z</lastUpdated>
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    <udiDi>06974318130008</udiDi>
    <basicUdiDi>697431813SEQSY</basicUdiDi>
    <tradeName>Genetic Sequencer DNBSEQ-G50</tradeName>
    <deviceName>Genetic Sequencer</deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</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>W02050108</emdnCode>
    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-000352-00</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:51:17.759Z</lastUpdated>
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    <udiDi>06974149860143</udiDi>
    <basicUdiDi>69741498614YV</basicUdiDi>
    <tradeName>06974149860143</tradeName>
    <deviceName>Ultrafast Real-Time PCR System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>H622202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:10.223Z</lastUpdated>
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    <basicUdiDi>69741498611YP</basicUdiDi>
    <tradeName>06974149860112</tradeName>
    <deviceName>Real-Time PCR System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <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>H621103，H621104，H621105，H621106</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:06.219Z</lastUpdated>
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    <basicUdiDi>697414986Auto12DxPQ</basicUdiDi>
    <tradeName>06974149860099</tradeName>
    <deviceName>Autoblot WB Process Station</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H351000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:05.432Z</lastUpdated>
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    <tradeName>06974149860068</tradeName>
    <deviceName>qMate Mini Nucleic Acid Extraction System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H691101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:04.628Z</lastUpdated>
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    <udiDi>06974149860051</udiDi>
    <basicUdiDi>697414986Kingwell96LE</basicUdiDi>
    <tradeName>06974149860051</tradeName>
    <deviceName>Kingwell Automated Thermal Cycler</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>H611101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:29:03.815Z</lastUpdated>
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    <udiDi>06974149860044</udiDi>
    <basicUdiDi>697414986ONEblotDxC6</basicUdiDi>
    <tradeName>06974149860044</tradeName>
    <deviceName>ONEblot Near-Field Chemi lmager</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H511001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:28:59.819Z</lastUpdated>
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    <udiDi>06974149860020</udiDi>
    <basicUdiDi>697414986XW3XH</basicUdiDi>
    <tradeName>06974149860020</tradeName>
    <deviceName>Aegaeon Digital PCR System</deviceName>
    <manufacturerName>Aperbio  Technologies  (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000045149</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H631104</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:28:58.214Z</lastUpdated>
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    <udiDi>06974081870484</udiDi>
    <basicUdiDi>697408187AccuRaMiniM6</basicUdiDi>
    <tradeName>Real-time PCR Quantitative Analyzer</tradeName>
    <deviceName>Real-time PCR Quantitative Analyzer</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:26:02.710Z</lastUpdated>
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    <tradeName>Real-time PCR Quantitative Analyzer</tradeName>
    <deviceName>Real-time PCR Quantitative Analyzer</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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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>052</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:26:01.914Z</lastUpdated>
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    <basicUdiDi>697384322FQD010GR</basicUdiDi>
    <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>
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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-A9600(EA4)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:04:56.219Z</lastUpdated>
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    <basicUdiDi>697384322FQD009H8</basicUdiDi>
    <tradeName>LineGene 9600 Pro Fluorescenct Quantitative Detection System</tradeName>
    <deviceName>LineGene 9600 Pro Fluorescenct 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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FQD-96A(ED2)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <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>
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    <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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    <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>
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    <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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    <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>
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    <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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    <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>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <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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