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    <tradeName>06974968581052</tradeName>
    <deviceName>Sequencing System</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQ00021</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:47:37.781Z</lastUpdated>
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    <basicUdiDi>697496858LabMDx-CECF</basicUdiDi>
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    <deviceName>Sequencing System</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>06974968581014</udiDi>
    <basicUdiDi>697496858Geno7Q</basicUdiDi>
    <tradeName>Single Molecule DNA Sequencer</tradeName>
    <deviceName>Single Molecule DNA Sequencer</deviceName>
    <manufacturerName>GeneMind Biosciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025785</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
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    <lastUpdated>2026-07-02T14:47:31.376Z</lastUpdated>
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    <basicUdiDi>697494499000RD</basicUdiDi>
    <tradeName>All-in-one Digital PCR Device</tradeName>
    <deviceName>All-in-one Digital PCR Device</deviceName>
    <manufacturerName>Suzhou Sniper Medical Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017448</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DQ24-Dx</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:46:08.058Z</lastUpdated>
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    <udiDi>06974901971384</udiDi>
    <basicUdiDi>69749019713LEIA**KP</basicUdiDi>
    <tradeName>Real-time PCR System</tradeName>
    <deviceName>Real-time PCR System</deviceName>
    <manufacturerName>Shandong Bohong Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025971</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>LEIA  series</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:42:53.328Z</lastUpdated>
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    <udiDi>06974901970011</udiDi>
    <basicUdiDi>6974901BH003U2</basicUdiDi>
    <tradeName>Nucleic Acid Extractor</tradeName>
    <deviceName>Nucleic Acid Extractor</deviceName>
    <manufacturerName>Shandong Bohong Gene Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025971</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>BH003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:42:46.140Z</lastUpdated>
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    <udiDi>26974900600173</udiDi>
    <basicUdiDi>697490060IPOCT-018K</basicUdiDi>
    <tradeName>26974900600173</tradeName>
    <deviceName>Palm Fluorescent PCR Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>IPOCT-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:42.882Z</lastUpdated>
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    <udiDi>16974900602026</udiDi>
    <basicUdiDi>697490060NARR-01RX</basicUdiDi>
    <tradeName>Nucleic Acid Release Reagent</tradeName>
    <deviceName>Nucleic Acid Release Reagent</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>NARR-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:40.479Z</lastUpdated>
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    <udiDi>16974900602019</udiDi>
    <basicUdiDi>697490060NAEM-01LD</basicUdiDi>
    <tradeName>Magnetic Bead Nucleic Acid Extraction Kit</tradeName>
    <deviceName>Magnetic Bead Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</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>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NAEM-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:38.885Z</lastUpdated>
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    <udiDi>16974900600183</udiDi>
    <basicUdiDi>697490060MC42-P01GV</basicUdiDi>
    <tradeName>16974900600183</tradeName>
    <deviceName>Real-time PCR Nucleic Acid Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</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>MC42-P01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:38.075Z</lastUpdated>
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    <udiDi>16974900600169</udiDi>
    <basicUdiDi>697490060AutoPocMDx2S</basicUdiDi>
    <tradeName>16974900600169</tradeName>
    <deviceName>Fully Automated PCR Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</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>AutoPoc MDx</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:36.501Z</lastUpdated>
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    <udiDi>16974900600091</udiDi>
    <basicUdiDi>697490060SWSI-0243</basicUdiDi>
    <tradeName>Hand-held Nucleic Acid Detection Analyzer</tradeName>
    <deviceName>Hand-held Nucleic Acid Detection Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>SWSI-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:34.082Z</lastUpdated>
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    <udiDi>16974900600039</udiDi>
    <basicUdiDi>697490060SWM-02PA</basicUdiDi>
    <tradeName>Real-time PCR Nucleic Acid Detection System</tradeName>
    <deviceName>Real-time PCR Nucleic Acid Detection System</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</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>SWM-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:31.676Z</lastUpdated>
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    <basicUdiDi>697490060SWM-01P8</basicUdiDi>
    <tradeName>PCR Nucleic Acid Analyzer</tradeName>
    <deviceName>PCR Nucleic Acid Analyzer</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:26.066Z</lastUpdated>
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    <tradeName>06974884777904</tradeName>
    <deviceName>PCR Thermal Cycler</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y007H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:24.363Z</lastUpdated>
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    <tradeName>06974884777867</tradeName>
    <deviceName>All-in-one Molecular Diagnosis System</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y035H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:22.761Z</lastUpdated>
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    <deviceName>Multichannel Fluorescence Quantitative Analyzer</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y016B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:17.163Z</lastUpdated>
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    <tradeName>06974884777638</tradeName>
    <deviceName>Automatic Nucleic Acid Workstation</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y064H</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:15.564Z</lastUpdated>
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    <tradeName>06974884777560</tradeName>
    <deviceName>Automated Nucleic Acid Extraction System</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
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    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y068H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:11.554Z</lastUpdated>
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    <tradeName>Nucleic Acid Extraction System</tradeName>
    <deviceName>Automatic Nucleic Acid Extractor</deviceName>
    <manufacturerName>Xi'an Tianlong Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001079</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y005H-KG-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:39:04.397Z</lastUpdated>
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