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    <deviceName>Real-time Fluorescent Quantitative PCR Analyzer</deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>BFQP-4820</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:44:48.127Z</lastUpdated>
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    <tradeName>GENEDIAN</tradeName>
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    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
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    <lastUpdated>2026-07-31T15:56:15.740Z</lastUpdated>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceName>Real-time Fluorescent Quantitative PCR Analyzer</deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-1620</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T03:56:38.029Z</lastUpdated>
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    <udiDi>06975514361050</udiDi>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <tradeName>06975514361050</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-1650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T03:46:39.297Z</lastUpdated>
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    <udiDi>06975514360077</udiDi>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <tradeName>06975514360077</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-482C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:06.955Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-484C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:06.022Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-485C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:05.772Z</lastUpdated>
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    <tradeName>06975514360046</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-9650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:05.322Z</lastUpdated>
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    <udiDi>06975514360084</udiDi>
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    <tradeName>06975514360084</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-965C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:04.475Z</lastUpdated>
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    <tradeName>06975514360022</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-4840</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:56.243Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFQP-4850</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:30.491Z</lastUpdated>
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    <tradeName>Veros COVID-19</tradeName>
    <deviceName>Veros COVID-19</deviceName>
    <manufacturerName>Sense Biodetection Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000022999</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD0004-SP-107</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:23:29.400Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HysenDx 200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:51:12.749Z</lastUpdated>
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    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MFIA02-E</reference>
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    <lastUpdated>2026-07-12T07:05:16.885Z</lastUpdated>
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    <tradeName>Truelab® Quattro</tradeName>
    <deviceName>Truelab® Quattro Real Time Quantitative micro PCR Analyzer</deviceName>
    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603023001</reference>
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    <lastUpdated>2026-07-03T19:06:18.929Z</lastUpdated>
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    <manufacturerSrn>IN-MF-000028386</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
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    <lastUpdated>2026-07-03T19:06:18.130Z</lastUpdated>
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    <manufacturerName>Molbio Diagnostics Limited</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>603021001</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:06:14.134Z</lastUpdated>
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    <tradeName>Rapi Q- Micro RT PCR System</tradeName>
    <deviceName>Rapi Q- Micro RT PCR System</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IG2M5001</reference>
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    <lastUpdated>2026-07-03T18:53:13.910Z</lastUpdated>
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    <tradeName>One PCR Ultra-Fast  RT PCR System</tradeName>
    <deviceName>One PCR Ultra-Fast RT PCR System</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
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    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-03T18:53:06.720Z</lastUpdated>
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