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    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Acid Extraction Reagents 1, 2 and 3</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240925</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:42:36.785Z</lastUpdated>
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    <udiDi>00382902409243</udiDi>
    <basicUdiDi>038290QRQTLGKVPL</basicUdiDi>
    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Enzyme Extraction</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240924</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:42:35.990Z</lastUpdated>
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    <udiDi>00382902409229</udiDi>
    <basicUdiDi>038290OGQXROZRMN</basicUdiDi>
    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Acid Test Latex B</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240922</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:42:31.971Z</lastUpdated>
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    <udiDi>00382902409588</udiDi>
    <basicUdiDi>038290GYMSVFYGMT</basicUdiDi>
    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Enzyme Test Latex A</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240958</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:48.038Z</lastUpdated>
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    <udiDi>00382902409380</udiDi>
    <basicUdiDi>038290MGGIBRZV8G</basicUdiDi>
    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Enzyme Test Latex D</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240938</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:44.045Z</lastUpdated>
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    <udiDi>00382902409304</udiDi>
    <basicUdiDi>038290LHRHITCLBL</basicUdiDi>
    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Acid Test Latex F</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240930</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:43.259Z</lastUpdated>
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    <udiDi>00382902409281</udiDi>
    <basicUdiDi>038290KOUWIZATNC</basicUdiDi>
    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Test Cards</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240928</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:42.434Z</lastUpdated>
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    <udiDi>00382902409236</udiDi>
    <basicUdiDi>038290GGXDCGRW7W</basicUdiDi>
    <tradeName>BBL</tradeName>
    <deviceName>BD BBL™ Streptocard™ Acid Test Latex A</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240923</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:41.636Z</lastUpdated>
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  <row>
    <udiDi>00382902409182</udiDi>
    <basicUdiDi>038290MPOMLCHHF6</basicUdiDi>
    <tradeName>BBL Streptocard</tradeName>
    <deviceName>BD BBL™ Streptocard™ Enzyme Latex Test Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240918</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:37.636Z</lastUpdated>
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  <row>
    <udiDi>00382902409175</udiDi>
    <basicUdiDi>038290INMITSBFD4</basicUdiDi>
    <tradeName>BBL Streptocard</tradeName>
    <deviceName>BD BBL™ Streptocard™ Acid Latex Test Kit</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>240917</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:32:36.832Z</lastUpdated>
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    <udiDi>06977597620291</udiDi>
    <basicUdiDi>B-06977597620291</basicUdiDi>
    <tradeName>06977597620291</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type IX）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:32.220Z</lastUpdated>
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    <udiDi>06977597620277</udiDi>
    <basicUdiDi>B-06977597620277</basicUdiDi>
    <tradeName>06977597620277</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type VII）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:27.514Z</lastUpdated>
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    <udiDi>06977597620260</udiDi>
    <basicUdiDi>B-06977597620260</basicUdiDi>
    <tradeName>06977597620260</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type VI）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:25.822Z</lastUpdated>
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    <udiDi>06977597620253</udiDi>
    <basicUdiDi>B-06977597620253</basicUdiDi>
    <tradeName>06977597620253</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type V）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:25.027Z</lastUpdated>
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    <basicUdiDi>B-06977597620246</basicUdiDi>
    <tradeName>06977597620246</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type IV）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:21.016Z</lastUpdated>
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    <basicUdiDi>B-06977597620239</basicUdiDi>
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    <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>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type III）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:20.227Z</lastUpdated>
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    <basicUdiDi>B-06977597620222</basicUdiDi>
    <tradeName>06977597620222</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type II）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:19.415Z</lastUpdated>
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    <basicUdiDi>B-06977597620215</basicUdiDi>
    <tradeName>06977597620215</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>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control（Type Ib）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:18.618Z</lastUpdated>
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    <basicUdiDi>B-06977597620208</basicUdiDi>
    <tradeName>06977597620208</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B antisera for quality control (Type Ia)</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:14.626Z</lastUpdated>
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    <basicUdiDi>B-06977597620192</basicUdiDi>
    <tradeName>06977597620192</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>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Streptococcus Group B  latex antisera（Type IX）</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:26:13.814Z</lastUpdated>
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