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    <deviceName>STREPTOCOCCAL GROUPING KIT</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0585A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:38.200Z</lastUpdated>
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  <row>
    <udiDi>05032384013043</udiDi>
    <basicUdiDi>5032384StrepGroupLatexPP</basicUdiDi>
    <tradeName>STREPTOCOCCAL GROUPING REAGENT A</tradeName>
    <deviceName>OXOID STREPTOCOCCAL GROUPING REAGENTS</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0586G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:38.177Z</lastUpdated>
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    <udiDi>05032384519552</udiDi>
    <basicUdiDi>5032384PathoDxtraStrepZC</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUPING KIT</tradeName>
    <deviceName>PATHODXTRA STREP GROUPING KIT</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0700M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.238Z</lastUpdated>
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    <udiDi>05032384519569</udiDi>
    <basicUdiDi>5032384PathoDxtraReagJQ</basicUdiDi>
    <tradeName>PATHODXTRA EXTRACTION REAGENTS</tradeName>
    <deviceName>PATHODXTRA EXTRACTION REAGENTS</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0709M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.214Z</lastUpdated>
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    <udiDi>05032384519576</udiDi>
    <basicUdiDi>5032384PathoDxtraRSetHV</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUPING REAGENT SET</tradeName>
    <deviceName>PATHODXTRA STREP GROUPING REAGENT SET</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0710M</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.186Z</lastUpdated>
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  <row>
    <udiDi>05032384519606</udiDi>
    <basicUdiDi>5032384PathoDxtraCardG8</basicUdiDi>
    <tradeName>PATHODXTRA DISPOSABLE CARDS</tradeName>
    <deviceName>PATHODXTRA DISPOSABLE CARDS</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0720G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.167Z</lastUpdated>
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    <udiDi>05032384519835</udiDi>
    <basicUdiDi>5032384PathoDxtraLatexTL</basicUdiDi>
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    <deviceName>PATHODXTRA STREP GROUP LATEX</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0701G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.123Z</lastUpdated>
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    <udiDi>05032384519842</udiDi>
    <basicUdiDi>5032384PathoDxtraLatexTL</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUP B LATEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0702G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.100Z</lastUpdated>
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    <udiDi>05032384519859</udiDi>
    <basicUdiDi>5032384PathoDxtraLatexTL</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUP C LATEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0703G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.076Z</lastUpdated>
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    <udiDi>05032384519866</udiDi>
    <basicUdiDi>5032384PathoDxtraLatexTL</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUP D LATEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0704G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.052Z</lastUpdated>
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    <basicUdiDi>5032384PathoDxtraLatexTL</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUP F LATEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0705G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.035Z</lastUpdated>
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    <basicUdiDi>5032384PathoDxtraLatexTL</basicUdiDi>
    <tradeName>PATHODXTRA STREP GROUP G LATEX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0706G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.012Z</lastUpdated>
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    <udiDi>05056080501536</udiDi>
    <basicUdiDi>50560805PathoDXCardE6</basicUdiDi>
    <tradeName>PATHODX DISPOSABLE SLIDES</tradeName>
    <deviceName>PATHODX DISPOSABLE SLIDES</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>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:31.952Z</lastUpdated>
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    <basicUdiDi>50560805StreptexCardM4</basicUdiDi>
    <tradeName>STREPTEX DISPOSABLE REACTION CARDS</tradeName>
    <deviceName>STREPTEX DISPOSABLE REACTION CARDS</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>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30368601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:31.151Z</lastUpdated>
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    <basicUdiDi>50560805StreptexAcidExtAE</basicUdiDi>
    <tradeName>STREPTEX ACID EXTRACTION KIT</tradeName>
    <deviceName>STREPTEX ACID EXTRACTION KIT</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>IVDR 2017/746</legislation>
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    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30951301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:11.879Z</lastUpdated>
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    <deviceName>STREPTEX EXTRACTION ENZYME</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
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    <reference>R30951001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:11.080Z</lastUpdated>
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    <basicUdiDi>50560805StreptexPC63</basicUdiDi>
    <tradeName>STREPTEX POLYVALENT POSITIVE CONTROL</tradeName>
    <deviceName>STREPTEX POLYVALENT POSITIVE CONTROL</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
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    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30164601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:09.479Z</lastUpdated>
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    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30950601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:07.425Z</lastUpdated>
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    <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>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30950555</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:05.475Z</lastUpdated>
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    <tradeName>STREPTEX</tradeName>
    <deviceName>STREPTEX</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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    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30950501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:23:04.695Z</lastUpdated>
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