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    <tradeName>Influenza A/B Rapid Test</tradeName>
    <deviceName>Influenza A/B Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIFLU-722</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:52.132Z</lastUpdated>
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    <udiDi>06976202762852</udiDi>
    <basicUdiDi>B-06976202762852</basicUdiDi>
    <tradeName>SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2/Influenza A+B/RSV/Adenovirus Ag Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GISFRA-702H</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:22.457Z</lastUpdated>
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    <udiDi>06976202762838</udiDi>
    <basicUdiDi>B-06976202762838</basicUdiDi>
    <tradeName>RSV/Influenza A+B Combo Rapid Test</tradeName>
    <deviceName>RSV/Influenza A+B Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIRF-732</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:18.447Z</lastUpdated>
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    <udiDi>06976202762845</udiDi>
    <basicUdiDi>B-06976202762845</basicUdiDi>
    <tradeName>SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test</tradeName>
    <deviceName>SARS-CoV-2/Influenza A+B/RSV Ag Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GISFR-742</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:16.857Z</lastUpdated>
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    <udiDi>06976202762807</udiDi>
    <basicUdiDi>B-06976202762807</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus Combo Test</tradeName>
    <deviceName>Rotavirus/Adenovirus Combo Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GINRA-632</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:16.169Z</lastUpdated>
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    <udiDi>06976202762760</udiDi>
    <basicUdiDi>B-06976202762760</basicUdiDi>
    <tradeName>Norovirus/Rotavirus/Adenovirus Combo Rapid Test</tradeName>
    <deviceName>Norovirus/Rotavirus/Adenovirus Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GINRA-632</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:10.440Z</lastUpdated>
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    <udiDi>06976202762364</udiDi>
    <basicUdiDi>B-06976202762364</basicUdiDi>
    <tradeName>Adenovirus/RSV/Influenza A+B Combo Rapid Test</tradeName>
    <deviceName>Adenovirus/RSV/Influenza A+B Combo Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIARF-742</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:59.158Z</lastUpdated>
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    <udiDi>06975578360150</udiDi>
    <basicUdiDi>B-06975578360150</basicUdiDi>
    <tradeName>06975578360150</tradeName>
    <deviceName>Invasive Fungal Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000244</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:08.186Z</lastUpdated>
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    <udiDi>06975578360143</udiDi>
    <basicUdiDi>B-06975578360143</basicUdiDi>
    <tradeName>06975578360143</tradeName>
    <deviceName>Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detection Kit (Digital PCR Method）</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000236</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:05.797Z</lastUpdated>
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    <udiDi>06975352996230</udiDi>
    <basicUdiDi>B-06975352996230</basicUdiDi>
    <tradeName>Comprehensive Pathogen NA Test Kit</tradeName>
    <deviceName>Comprehensive Pathogen NA Test Kit</deviceName>
    <manufacturerName>Suzhou GenePlus Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035774</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101122103</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:10.562Z</lastUpdated>
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    <udiDi>06974689627299</udiDi>
    <basicUdiDi>B-06974689627299</basicUdiDi>
    <tradeName>Meningitis/Encephalitis (ME) pathogens digital PCR detection kit</tradeName>
    <deviceName>Meningitis/Encephalitis (ME) pathogens digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13699-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:49.882Z</lastUpdated>
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    <udiDi>06974689626568</udiDi>
    <basicUdiDi>B-06974689626568</basicUdiDi>
    <tradeName>Meningitis/Encephalitis (ME) pathogens digital PCR detection kit</tradeName>
    <deviceName>Meningitis/Encephalitis (ME) pathogens digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13699-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:55.057Z</lastUpdated>
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    <udiDi>06974566303957</udiDi>
    <basicUdiDi>B-06974566303957</basicUdiDi>
    <tradeName>Bacterial Vaginosis(BV) Test</tradeName>
    <deviceName>Bacterial Vaginosis(BV) Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:33.671Z</lastUpdated>
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    <udiDi>06974566303940</udiDi>
    <basicUdiDi>B-06974566303940</basicUdiDi>
    <tradeName>Bacterial Vaginosis(BV) Test</tradeName>
    <deviceName>Bacterial Vaginosis(BV) Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BV20</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:32.863Z</lastUpdated>
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    <udiDi>06974566303773</udiDi>
    <basicUdiDi>B-06974566303773</basicUdiDi>
    <tradeName>Respiratory Pathogen Antigen Rapid Test</tradeName>
    <deviceName>Respiratory Pathogen Antigen Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSA-0201</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:05.653Z</lastUpdated>
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    <udiDi>06974566303766</udiDi>
    <basicUdiDi>B-06974566303766</basicUdiDi>
    <tradeName>Respiratory Pathogen Antigen Rapid Test</tradeName>
    <deviceName>Respiratory Pathogen Antigen Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSA-02020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:03.250Z</lastUpdated>
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    <udiDi>06974566303759</udiDi>
    <basicUdiDi>B-06974566303759</basicUdiDi>
    <tradeName>Respiratory Pathogen Antigen Rapid Test</tradeName>
    <deviceName>Respiratory Pathogen Antigen Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSA-02025</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:58:01.647Z</lastUpdated>
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    <udiDi>06974566303650</udiDi>
    <basicUdiDi>B-06974566303650</basicUdiDi>
    <tradeName>Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH,CV,TV)</tradeName>
    <deviceName>Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH,CV,TV)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S0007-20</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:48.038Z</lastUpdated>
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    <udiDi>06974566303674</udiDi>
    <basicUdiDi>B-06974566303674</basicUdiDi>
    <tradeName>Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH,CV,TV)</tradeName>
    <deviceName>Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH,CV,TV)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S0007-1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:46.542Z</lastUpdated>
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    <udiDi>06974566303643</udiDi>
    <basicUdiDi>B-06974566303643</basicUdiDi>
    <tradeName>Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH)</tradeName>
    <deviceName>Bacterial Vaginosis combo Test (H2O2 ,SA,LE,PH)</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S0004</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:32.796Z</lastUpdated>
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