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    <udiDi>06975489971001</udiDi>
    <basicUdiDi>697548997CDP304TH</basicUdiDi>
    <tradeName>TIANamp Genomic DNA Kit</tradeName>
    <deviceName>TIANamp Genomic DNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP304-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:07.590Z</lastUpdated>
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    <udiDi>06975489971032</udiDi>
    <basicUdiDi>697548997CDP315-RA3</basicUdiDi>
    <tradeName>TIANamp Virus RNA Kit</tradeName>
    <deviceName>TIANamp Virus RNA Kit</deviceName>
    <manufacturerName>Tiangen Biotech (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026594</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDP315-R</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:06.792Z</lastUpdated>
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    <udiDi>06975467551027</udiDi>
    <basicUdiDi>697546755102PF</basicUdiDi>
    <tradeName>06975467551027</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Beijing USCI Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026308</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USCI-TQ003</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:06:04.828Z</lastUpdated>
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    <udiDi>06975467551041</udiDi>
    <basicUdiDi>697546755104PK</basicUdiDi>
    <tradeName>06975467551041</tradeName>
    <deviceName>Nucleic Acid Purification Kit</deviceName>
    <manufacturerName>Beijing USCI Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026308</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USCI-CH001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:06:02.421Z</lastUpdated>
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    <udiDi>06975394010017</udiDi>
    <basicUdiDi>697539401SWP10S4</basicUdiDi>
    <tradeName>RNXtract® Nucleic Acid Extraction Kit</tradeName>
    <deviceName>RNXtract® Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Shuwen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034318</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWP10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:02.950Z</lastUpdated>
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    <udiDi>06975225660626</udiDi>
    <basicUdiDi>697522566PRO0001VC</basicUdiDi>
    <tradeName>Genetic Sequencer</tradeName>
    <deviceName>Genetic Sequencer</deviceName>
    <manufacturerName>Shenzhen Salus BioMed Co.. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036126</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-09</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:17.820Z</lastUpdated>
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    <udiDi>06975225660602</udiDi>
    <basicUdiDi>697522566SalusEVOYL</basicUdiDi>
    <tradeName>Genetic Sequencer (Salus EVO)</tradeName>
    <deviceName>Genetic Sequencer (Salus EVO)</deviceName>
    <manufacturerName>Shenzhen Salus BioMed Co.. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036126</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:17.019Z</lastUpdated>
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    <udiDi>06975225660596</udiDi>
    <basicUdiDi>697522566SaluseqNimbo6X</basicUdiDi>
    <tradeName>Genetic Sequencer (Saluseq Nimbo)</tradeName>
    <deviceName>Saluseq Nimbo</deviceName>
    <manufacturerName>Shenzhen Salus BioMed Co.. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036126</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:16.224Z</lastUpdated>
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    <udiDi>06975225660534</udiDi>
    <basicUdiDi>697522566evo4L</basicUdiDi>
    <tradeName>06975225660534</tradeName>
    <deviceName>Salus EVO Sequencing Reagent Set</deviceName>
    <manufacturerName>Shenzhen Salus BioMed Co.. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036126</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16-90-90-01-90</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:12.219Z</lastUpdated>
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    <udiDi>06975225660473</udiDi>
    <basicUdiDi>697522566nimboFT</basicUdiDi>
    <tradeName>Saluseq Nimbo Sequencing Reagent Set</tradeName>
    <deviceName>Saluseq Nimbo Sequencing Reagent Set</deviceName>
    <manufacturerName>Shenzhen Salus BioMed Co.. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036126</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:11.426Z</lastUpdated>
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    <udiDi>06975225660008</udiDi>
    <basicUdiDi>697522566pro5X</basicUdiDi>
    <tradeName>06975225660008</tradeName>
    <deviceName>Salus Pro Sequencing Reagent Set</deviceName>
    <manufacturerName>Shenzhen Salus BioMed Co.. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036126</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:29:10.620Z</lastUpdated>
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    <udiDi>06975212990019</udiDi>
    <basicUdiDi>697521299R1120D9</basicUdiDi>
    <tradeName>06975212990019</tradeName>
    <deviceName>Library Preparation Kit For Next Generation Sequencing</deviceName>
    <manufacturerName>Wuhan Healthy Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022801</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1120</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:28:11.342Z</lastUpdated>
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    <udiDi>06975139678083</udiDi>
    <basicUdiDi>697513967OPBT0063M</basicUdiDi>
    <tradeName>06975139678083</tradeName>
    <deviceName>DNA Isolation and Purifying kit</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:15:03.110Z</lastUpdated>
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    <udiDi>06975139678052</udiDi>
    <basicUdiDi>697513967OPBT0073P</basicUdiDi>
    <tradeName>06975139678052</tradeName>
    <deviceName>DNA Isolation and Methylate Preparation Kit</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:14:59.106Z</lastUpdated>
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    <udiDi>06975139678014</udiDi>
    <basicUdiDi>697513967OPBT0053K</basicUdiDi>
    <tradeName>06975139678014</tradeName>
    <deviceName>DNA Methylation-Lightning MagPrep</deviceName>
    <manufacturerName>Beijing OriginPoly Bio-Tec Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043242</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:14:58.429Z</lastUpdated>
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    <udiDi>06975029660143</udiDi>
    <basicUdiDi>697502966014LD</basicUdiDi>
    <tradeName>DNA Extraction or Purification Kit</tradeName>
    <deviceName>DNA Extraction or Purification Kit</deviceName>
    <manufacturerName>Genetron Health (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000046433</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:55:11.873Z</lastUpdated>
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    <udiDi>06974969983473</udiDi>
    <basicUdiDi>697496998ZD007YR</basicUdiDi>
    <tradeName>PCR Master Mix</tradeName>
    <deviceName>PCR Master Mix</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZD007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:48:22.664Z</lastUpdated>
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    <udiDi>06974968583858</udiDi>
    <basicUdiDi>697496858BZ01UU</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>FASTASeq S Dx Universal Reaction Kit for Sequencing</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>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S000495</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:48:09.859Z</lastUpdated>
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    <udiDi>06974968583766</udiDi>
    <basicUdiDi>697496858BU01U3</basicUdiDi>
    <tradeName>GeneMind</tradeName>
    <deviceName>SURFSeq Q Dx Universal Reaction Kit for Sequencing</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>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S000426</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:48:09.059Z</lastUpdated>
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    <udiDi>06974968583407</udiDi>
    <basicUdiDi>697496858BR01SURF50005C</basicUdiDi>
    <tradeName>06974968583407</tradeName>
    <deviceName>SURFSeq 5000 Dx Universial Reaction Kit for Sequencing</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>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S000222</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:48:07.460Z</lastUpdated>
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