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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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  <row>
    <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>D-TD-HNVC-CED-04X8</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-04X8</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-04X8</tradeName>
    <deviceName>Beta-haemolytic Group B Streptococcus Nucleic Acid Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Henan Vacure Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023292</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:56.304Z</lastUpdated>
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  <row>
    <udiDi>D-TD-HNVC-CED-03X6</udiDi>
    <basicUdiDi>B-TD-HNVC-CED-03X6</basicUdiDi>
    <tradeName>D-TD-HNVC-CED-03X6</tradeName>
    <deviceName>Beta-haemolytic Group A Streptococcus Nucleic Acid Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Henan Vacure Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023292</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:57:55.505Z</lastUpdated>
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  <row>
    <udiDi>D-ST06N8</udiDi>
    <basicUdiDi>B-ST06N8</basicUdiDi>
    <tradeName>Cowingene Group B Streptococcus Detection Kit</tradeName>
    <deviceName>Cowingene Group B Streptococcus Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST06011X, ST06012X, ST06013W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:42:19.620Z</lastUpdated>
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  <row>
    <udiDi>D-JB20112NW-50TNC</udiDi>
    <basicUdiDi>B-JB20112NW-50TNC</basicUdiDi>
    <tradeName>Group B Streptococcus Real Time PCR Kit</tradeName>
    <deviceName>Group B Streptococcus Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB20112NW-50T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:29.536Z</lastUpdated>
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  <row>
    <udiDi>D-JB20112NW-25TNC</udiDi>
    <basicUdiDi>B-JB20112NW-25TNC</basicUdiDi>
    <tradeName>Group B Streptococcus Real Time PCR Kit</tradeName>
    <deviceName>Group B Streptococcus Real Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Bioperfectus Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014691</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JB20112NW-25T</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:22:28.739Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-70-01-40VW</udiDi>
    <basicUdiDi>B-CDX-70-01-40VW</basicUdiDi>
    <tradeName>GenomEra® S. pneumoniae Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-70-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:25.703Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-70-01-40URA</udiDi>
    <basicUdiDi>B-CDX-70-01-40URA</basicUdiDi>
    <tradeName>GenomEra S. pneumoniae Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-70-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:24.904Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-70-01-20VQ</udiDi>
    <basicUdiDi>B-CDX-70-01-20VQ</basicUdiDi>
    <tradeName>GenomEra® S. pneumoniae Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-70-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:24.100Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-70-01-20UQY</udiDi>
    <basicUdiDi>B-CDX-70-01-20UQY</basicUdiDi>
    <tradeName>GenomEra S. pneumoniae Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-70-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:23.299Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-60-01-40VB</udiDi>
    <basicUdiDi>B-CDX-60-01-40VB</basicUdiDi>
    <tradeName>GenomEra® GBS Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-60-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:19.297Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-60-01-40UQK</udiDi>
    <basicUdiDi>B-CDX-60-01-40UQK</basicUdiDi>
    <tradeName>GenomEra GBS Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-60-01-40</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:18.499Z</lastUpdated>
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  <row>
    <udiDi>D-CDX-60-01-20V5</udiDi>
    <basicUdiDi>B-CDX-60-01-20V5</basicUdiDi>
    <tradeName>GenomEra® GBS Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-60-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:17.693Z</lastUpdated>
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    <udiDi>D-CDX-60-01-20UQ9</udiDi>
    <basicUdiDi>B-CDX-60-01-20UQ9</basicUdiDi>
    <tradeName>GenomEra GBS Assay Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CDX-60-01-20</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:00:16.894Z</lastUpdated>
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    <udiDi>D-888501395GBGBSKH</udiDi>
    <basicUdiDi>B-888501395GBGBSKH</basicUdiDi>
    <tradeName>Great Basin Group B Streptococcus Test</tradeName>
    <deviceName>Great Basin Group B Streptococcus Test</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300781</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:33.327Z</lastUpdated>
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    <udiDi>D-84295773165WYH9</udiDi>
    <basicUdiDi>B-84295773165WYH9</basicUdiDi>
    <tradeName>S. PneumoStrip</tradeName>
    <deviceName>S. PneumoStrip</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3.165.XXX.YY.ZZZ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:08:31.732Z</lastUpdated>
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    <udiDi>D-81649002RGAS01JKST</udiDi>
    <basicUdiDi>B-81649002RGAS01JKST</basicUdiDi>
    <tradeName>D-81649002RGAS01JKST</tradeName>
    <deviceName>Rapid Group A Streptococcus DNA Test</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RGAS01-AHG5E/ RGAS01-AHG25E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:21.747Z</lastUpdated>
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