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    <tradeName>06975514360015</tradeName>
    <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-4820</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:44:48.127Z</lastUpdated>
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    <udiDi>06934244500139</udiDi>
    <basicUdiDi>69342445IA002FK</basicUdiDi>
    <tradeName>GENEDIAN</tradeName>
    <deviceName>iRapid4 POC RT-PCR Detection System</deviceName>
    <manufacturerName>Hangzhou DIAN Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007252</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</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>AB pazarı için değil</deviceStatus>
    <reference>P114-00004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:56:15.740Z</lastUpdated>
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    <tradeName>06975514361043</tradeName>
    <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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    <udiDi>06975514360053</udiDi>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <tradeName>06975514360053</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-484C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:06.022Z</lastUpdated>
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    <udiDi>06975514360060</udiDi>
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    <tradeName>06975514360060</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-485C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:05.772Z</lastUpdated>
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    <udiDi>06975514360046</udiDi>
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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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    <udiDi>06975514360022</udiDi>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <tradeName>06975514360022</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-4840</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:52:56.243Z</lastUpdated>
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    <udiDi>06975514360039</udiDi>
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    <tradeName>06975514360039</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-4850</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:30.491Z</lastUpdated>
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    <udiDi>50608178000140</udiDi>
    <basicUdiDi>B-50608178000140</basicUdiDi>
    <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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    <udiDi>08809975890034</udiDi>
    <basicUdiDi>88099758902007000182</basicUdiDi>
    <tradeName>08809975890034</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hysen Biotech.Inc</manufacturerName>
    <manufacturerSrn>KR-MF-000048224</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>HysenDx 200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:51:12.749Z</lastUpdated>
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    <udiDi>D-81649002MFIA02F7JY</udiDi>
    <basicUdiDi>B-81649002MFIA02F7JY</basicUdiDi>
    <tradeName>D-81649002MFIA02F7JY</tradeName>
    <deviceName>Gene Scoper</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</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>MFIA02-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:16.885Z</lastUpdated>
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    <udiDi>08906178200698</udiDi>
    <basicUdiDi>890617820IG2M5001KQ</basicUdiDi>
    <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>
    <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>IG2M5001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:13.910Z</lastUpdated>
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    <udiDi>08906178200162</udiDi>
    <basicUdiDi>890617820IG2M5001UF9L</basicUdiDi>
    <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>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>IG2M5001UF</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:06.720Z</lastUpdated>
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    <tradeName>06979117020017</tradeName>
    <deviceName>G-seq500 Single Molecule Sequencer</deviceName>
    <manufacturerName>Geneus Technologies (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050313</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G-seq500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:26:19.319Z</lastUpdated>
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    <udiDi>06978507780173</udiDi>
    <basicUdiDi>697850778PCR10TL</basicUdiDi>
    <tradeName>Real-time PCR System</tradeName>
    <deviceName>Real-time PCR System</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048840</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</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>IN0109</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:37:27.480Z</lastUpdated>
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    <udiDi>06978380060003</udiDi>
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    <tradeName>06978380060003</tradeName>
    <deviceName>Mini PCR</deviceName>
    <manufacturerName>Suzhou Changhe Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045901</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HTM-8T</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:29:34.763Z</lastUpdated>
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    <basicUdiDi>697753746CW07RE</basicUdiDi>
    <tradeName>NATBox System</tradeName>
    <deviceName>NATBox System</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</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>CW07023Q</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:41:14.123Z</lastUpdated>
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