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    <manufacturerName>Remel Europe Ltd</manufacturerName>
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    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
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    <manufacturerName>Remel Europe Ltd</manufacturerName>
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    <manufacturerName>Remel Europe Ltd</manufacturerName>
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    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
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    <basicUdiDi>50560805StreptexLatexRS</basicUdiDi>
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    <manufacturerName>Remel Europe Ltd</manufacturerName>
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    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
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    <reference>R30950901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <udiDi>05056080501444</udiDi>
    <basicUdiDi>50560805StreptexLatexRS</basicUdiDi>
    <tradeName>STREPTEX LATEX F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30951101</reference>
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    <lastUpdated>2026-07-20T08:27:16.320Z</lastUpdated>
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    <basicUdiDi>50560805StreptexLatexRS</basicUdiDi>
    <tradeName>STREPTEX LATEX G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
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    <reference>R30951201</reference>
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    <lastUpdated>2026-07-20T08:27:16.298Z</lastUpdated>
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    <udiDi>69743840312614</udiDi>
    <basicUdiDi>B-69743840312614</basicUdiDi>
    <tradeName>Streptococcus pneumoniae antigen rapid test</tradeName>
    <deviceName>Streptococcus pneumoniae antigen rapid test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <tradeName>Strep B Rapid Test Device (Swab)</tradeName>
    <deviceName>Strep B Rapid Test Device (Swab)</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3026201</reference>
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    <lastUpdated>2026-07-17T01:11:47.911Z</lastUpdated>
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    <udiDi>D-1R11EG</udiDi>
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    <tradeName>mariPOC® Pneumococcus respiratory test reagent</tradeName>
    <deviceName>mariPOC® Pneumococcus respiratory test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R11</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:26:11.990Z</lastUpdated>
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    <udiDi>D-1R02EF</udiDi>
    <basicUdiDi>B-1R02EF</basicUdiDi>
    <tradeName>mariPOC® Group A streptococcus test reagent</tradeName>
    <deviceName>mariPOC® Group A streptococcus test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1R02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:17:54.403Z</lastUpdated>
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    <udiDi>06977597620284</udiDi>
    <basicUdiDi>B-06977597620284</basicUdiDi>
    <tradeName>06977597620284</tradeName>
    <deviceName>Streptococcus Group B antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality contro（Type VIII）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:28.210Z</lastUpdated>
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    <basicUdiDi>B-06977597620109</basicUdiDi>
    <tradeName>06977597620109</tradeName>
    <deviceName>Streptococcus Group B antisera</deviceName>
    <manufacturerName>Genhawk (Wuhan) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042707</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B latex antisera (Type Ia)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:24:13.476Z</lastUpdated>
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    <udiDi>06974854620568</udiDi>
    <basicUdiDi>B-06974854620568</basicUdiDi>
    <tradeName>Group B Streptococcus Antigen Test Kit</tradeName>
    <deviceName>Group B Streptococcus Antigen Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2200825</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:53.843Z</lastUpdated>
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    <basicUdiDi>B-06974854620551</basicUdiDi>
    <tradeName>Group A Streptococcus Antigen Test Kit</tradeName>
    <deviceName>Group A Streptococcus Antigen Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2200725</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:36.980Z</lastUpdated>
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    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISA-502</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:36.052Z</lastUpdated>
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    <tradeName>Strep B Rapid Test</tradeName>
    <deviceName>Strep B Rapid Test</deviceName>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:35.255Z</lastUpdated>
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    <tradeName>Strep A Antigen Rapid Test</tradeName>
    <deviceName>Strep A Antigen Rapid Test</deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSTR034GA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:00:05.765Z</lastUpdated>
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    <tradeName>StrongStep® Strep B Antigen Rapid Test</tradeName>
    <deviceName>Strep B Antigen Rapid Test</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500090</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:52:28.518Z</lastUpdated>
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    <tradeName>StrongStep® Strep A Antigen Rapid Test</tradeName>
    <deviceName>Strep A Antigen Rapid Test</deviceName>
    <manufacturerName>Nanjing Liming Bio-products Co. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041298</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T13:52:22.114Z</lastUpdated>
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    <tradeName>STREPTATEST</tradeName>
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    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:48:21.880Z</lastUpdated>
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