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    <tradeName>D-69509960SNCE07XHBY</tradeName>
    <deviceName>Viral Nucleic Acid Extraction Kit (Spin Column)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNCE07-AOG50E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:53:16.516Z</lastUpdated>
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    <udiDi>D-69509960SNCE05XDBE</udiDi>
    <basicUdiDi>B-69509960SNCE05XDBE</basicUdiDi>
    <tradeName>D-69509960SNCE05XDBE</tradeName>
    <deviceName>Nucleic Acid Extraction or Purification Kit</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNCE05-BOG48E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:53:15.188Z</lastUpdated>
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    <udiDi>D-69509960SNCE01X59W</udiDi>
    <basicUdiDi>B-69509960SNCE01X59W</basicUdiDi>
    <tradeName>D-69509960SNCE01X59W</tradeName>
    <deviceName>Viral Nucleic Acid Extraction Kit (Magnetic Beads)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNCE01-AOG48/ SNCE01-AOG96/ SNCE02-AOG16/ SNCE02-AOG48/ SNCE02-AOG96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:53:14.937Z</lastUpdated>
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    <udiDi>D-5061021472257PJ</udiDi>
    <basicUdiDi>B-5061021472257PJ</basicUdiDi>
    <tradeName>TRUPCR® Total Nucleic Acid Extraction Kit (500ul)</tradeName>
    <deviceName>TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B213</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:34:55.447Z</lastUpdated>
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    <udiDi>D-5061021472240NZ</udiDi>
    <basicUdiDi>B-5061021472240NZ</basicUdiDi>
    <tradeName>TRUPCR® BS DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® BS DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B215</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:34:55.198Z</lastUpdated>
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    <udiDi>08906213931327</udiDi>
    <basicUdiDi>8906213933B213BTG</basicUdiDi>
    <tradeName>TRUPCR® Magbead Viral RNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Magbead Viral RNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B213B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:59.705Z</lastUpdated>
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    <udiDi>08906213931297</udiDi>
    <basicUdiDi>8906213933B336YU</basicUdiDi>
    <tradeName>TRUPCR® Magbead Total Viral Nucleic Acid Extraction Kit</tradeName>
    <deviceName>TRUPCR® Magbead Total Viral Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B336</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:54.401Z</lastUpdated>
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    <udiDi>08906213931266</udiDi>
    <basicUdiDi>8906213933B339Z2</basicUdiDi>
    <tradeName>TRUPCR® Magbead Total Nucleic Acid Extraction Kit</tradeName>
    <deviceName>TRUPCR® Magbead Total Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B339</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:53.591Z</lastUpdated>
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    <udiDi>08906213931228</udiDi>
    <basicUdiDi>8906213933B334YQ</basicUdiDi>
    <tradeName>TRUPCR® Magbead Tissue DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Magbead Tissue DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B334</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:52.781Z</lastUpdated>
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    <udiDi>08906213931204</udiDi>
    <basicUdiDi>8906213933B337YW</basicUdiDi>
    <tradeName>TRUPCR® Magbead MTB/NTM DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Magbead MTB/NTM DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B437</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:52.007Z</lastUpdated>
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    <udiDi>08906213931174</udiDi>
    <basicUdiDi>8906213933B335YS</basicUdiDi>
    <tradeName>TRUPCR® Magbead FFPE Tissue DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Magbead FFPE Tissue DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B335</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:47.976Z</lastUpdated>
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    <udiDi>08906213931143</udiDi>
    <basicUdiDi>8906213933B333YN</basicUdiDi>
    <tradeName>TRUPCR® Magbead Blood DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Magbead Blood DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B333</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:47.183Z</lastUpdated>
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    <udiDi>08906213931129</udiDi>
    <basicUdiDi>8906213933B1401EQU</basicUdiDi>
    <tradeName>TRUPCR® Panel Extraction Kit</tradeName>
    <deviceName>TRUPCR® Panel Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1401E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:46.378Z</lastUpdated>
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    <udiDi>08906213931105</udiDi>
    <basicUdiDi>8906213933B207YG</basicUdiDi>
    <tradeName>TRUPCR® Tissue DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Tissue DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:45.580Z</lastUpdated>
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    <udiDi>08906213931068</udiDi>
    <basicUdiDi>8906213933B215YF</basicUdiDi>
    <tradeName>TRUPCR® BS DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® BS DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B215</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:41.792Z</lastUpdated>
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    <udiDi>08906213931082</udiDi>
    <basicUdiDi>8906213933B207FTX</basicUdiDi>
    <tradeName>TRUPCR® FFPE Tissue DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® FFPE Tissue DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B207F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:41.785Z</lastUpdated>
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    <udiDi>08906213931044</udiDi>
    <basicUdiDi>8906213933B1200S3</basicUdiDi>
    <tradeName>TRUPCR® Blood RNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Blood RNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:41.711Z</lastUpdated>
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    <udiDi>08906213931013</udiDi>
    <basicUdiDi>8906213933B205YC</basicUdiDi>
    <tradeName>TRUPCR® Blood DNA Extraction Kit</tradeName>
    <deviceName>TRUPCR® Blood DNA Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:40.658Z</lastUpdated>
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    <udiDi>08906213930948</udiDi>
    <basicUdiDi>8906213933B213YB</basicUdiDi>
    <tradeName>TRUPCR® Total Viral Nucleic Acid Extraction Kit</tradeName>
    <deviceName>TRUPCR® Total Viral Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:35.997Z</lastUpdated>
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    <basicUdiDi>8906213933B347YZ</basicUdiDi>
    <tradeName>TRUPCR® Total Nucleic Acid Extraction Kit</tradeName>
    <deviceName>TRUPCR® Total Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B347</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:53:34.372Z</lastUpdated>
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