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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>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC-96D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T14:28:05.474Z</lastUpdated>
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    <udiDi>06975514360862</udiDi>
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    <tradeName>06975514360862</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>IVDR 2017/746</legislation>
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    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC-384G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T14:28:05.444Z</lastUpdated>
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    <udiDi>06975514360879</udiDi>
    <basicUdiDi>697551436ThermalcyclerDH</basicUdiDi>
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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>
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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>FC-1536G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T14:28:05.419Z</lastUpdated>
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    <udiDi>06975514360886</udiDi>
    <basicUdiDi>697551436ThermalcyclerDH</basicUdiDi>
    <tradeName>06975514360886</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>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC-48D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T14:28:05.389Z</lastUpdated>
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    <udiDi>06975514360893</udiDi>
    <basicUdiDi>697551436ThermalcyclerDH</basicUdiDi>
    <tradeName>06975514360893</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>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC-48T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T14:28:05.360Z</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>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <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>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <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>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <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>
  </row>
  <row>
    <udiDi>37604277000578</udiDi>
    <basicUdiDi>376042770SEQUENCE86</basicUdiDi>
    <tradeName>Sequence Evolution IVD</tradeName>
    <deviceName>Sequence IVD</deviceName>
    <manufacturerName>AD Nucleis</manufacturerName>
    <manufacturerSrn>FR-MF-000002215</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>SEQ_EVO_IVD</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:48:23.247Z</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>
  </row>
  <row>
    <udiDi>37604277000646</udiDi>
    <basicUdiDi>376042770SEQUENCE86</basicUdiDi>
    <tradeName>Sequence PREP IVD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AD Nucleis</manufacturerName>
    <manufacturerSrn>FR-MF-000002215</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>SEQ_PREP_IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:51:31.945Z</lastUpdated>
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    <udiDi>06975514360039</udiDi>
    <basicUdiDi>697551436BFQP001PX</basicUdiDi>
    <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>
  </row>
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    <udiDi>03573026471859</udiDi>
    <basicUdiDi>357302BUDI000544TP</basicUdiDi>
    <tradeName>EMAG®</tradeName>
    <deviceName>EMAG®</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>418591</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:48.237Z</lastUpdated>
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    <udiDi>08595696306526</udiDi>
    <basicUdiDi>859569630080QR</basicUdiDi>
    <tradeName>myCROBE® Fully Automated Instrument</tradeName>
    <deviceName>myCROBE® Fully Automated Instrument</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MC100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:38.915Z</lastUpdated>
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    <udiDi>08595696302955</udiDi>
    <basicUdiDi>859569630053QN</basicUdiDi>
    <tradeName>croBEE® 2.0 Nucleic Acid Extraction System</tradeName>
    <deviceName>croBEE® 2.0 Nucleic Acid Extraction System</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CB2NA100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:37.376Z</lastUpdated>
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    <udiDi>08595696302450</udiDi>
    <basicUdiDi>859569630047QT</basicUdiDi>
    <tradeName>croBEE Real-Time PCR System</tradeName>
    <deviceName>croBEE Real-Time PCR System</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CBRT5/96</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:34.110Z</lastUpdated>
  </row>
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    <udiDi>08595696300050</udiDi>
    <basicUdiDi>859569630052QL</basicUdiDi>
    <tradeName>myCROBE® Fully Automated Instrument</tradeName>
    <deviceName>myCROBE® Fully Automated Instrument</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>MC100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:55:32.508Z</lastUpdated>
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    <udiDi>08595696302467</udiDi>
    <basicUdiDi>859569630047QT</basicUdiDi>
    <tradeName>croBEE Real-Time PCR System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>CBRT4/96</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:13.066Z</lastUpdated>
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