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    <tradeName>MutaPLEX® GBS (Group B Streptococci), PCR</tradeName>
    <deviceName>MutaPLEX® GBS (Group B Streptococci), PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <basicUdiDi>B-04050598002272</basicUdiDi>
    <tradeName>MutaPLEX® GBS (Group B Streptococci), PCR</tradeName>
    <deviceName>MutaPLEX® GBS (Group B Streptococci), PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>Toda Strepdiag B 1</tradeName>
    <deviceName>Toda Strepdiag B</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T18:59:06.800Z</lastUpdated>
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    <tradeName>Toda Strepdiag B 10</tradeName>
    <deviceName>Toda Strepdiag B 10</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
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    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:59:05.193Z</lastUpdated>
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    <udiDi>03760309510026</udiDi>
    <basicUdiDi>B-03760309510026</basicUdiDi>
    <tradeName>Toda Strepdiag A</tradeName>
    <deviceName>Toda Strepdiag A</deviceName>
    <manufacturerName>TODA PHARMA</manufacturerName>
    <manufacturerSrn>FR-MF-000007152</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1062</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:58:16.321Z</lastUpdated>
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    <udiDi>03532679226605</udiDi>
    <basicUdiDi>B-03532679226605</basicUdiDi>
    <tradeName>STREPTATEST</tradeName>
    <deviceName>STREPTATEST</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</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>10025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:48:21.880Z</lastUpdated>
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    <udiDi>03532678603599</udiDi>
    <basicUdiDi>B-03532678603599</basicUdiDi>
    <tradeName>STREPTATEST</tradeName>
    <deviceName>STREPTATEST</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</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>10025ND</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:48:01.090Z</lastUpdated>
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    <tradeName>BACTIDROP DESOXYCHOLATE (10%)</tradeName>
    <deviceName>BACTIDROP DESOXYCHOLATE</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21508</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:42.917Z</lastUpdated>
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    <udiDi>15420045510890</udiDi>
    <basicUdiDi>54200455DIAGPFGBSS3</basicUdiDi>
    <tradeName>Panther Fusion GBS Assay</tradeName>
    <deviceName>Panther Fusion GBS Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04484</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T01:06:22.968Z</lastUpdated>
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    <udiDi>03532678599700</udiDi>
    <basicUdiDi>353267F00157P8N</basicUdiDi>
    <tradeName>BIOSYNEX AMPLIFLASH GBS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3150072</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:26:36.252Z</lastUpdated>
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    <udiDi>06973492240183</udiDi>
    <basicUdiDi>697349224U2030112C000EU</basicUdiDi>
    <tradeName>EasyNAT GBS Assay</tradeName>
    <deviceName>EasyNAT GBS Assay</deviceName>
    <manufacturerName>Ustar Biotechnologies (Hangzhou) Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014615</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U20311</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:04:30.430Z</lastUpdated>
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    <udiDi>15420045510906</udiDi>
    <basicUdiDi>54200455DIAGPFGBSS3</basicUdiDi>
    <tradeName>Panther Fusion GBS Controls Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-04485</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:47:59.330Z</lastUpdated>
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    <udiDi>06955792700901</udiDi>
    <basicUdiDi>69557927S3056E000001S7</basicUdiDi>
    <tradeName>06955792700901</tradeName>
    <deviceName>Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3056E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:20:04.136Z</lastUpdated>
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    <basicUdiDi>69557927S3056E000001S7</basicUdiDi>
    <tradeName>06955792700895</tradeName>
    <deviceName>Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3056E-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:20:01.735Z</lastUpdated>
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    <basicUdiDi>B-06950917910555</basicUdiDi>
    <tradeName>06950917910555</tradeName>
    <deviceName>Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent PCR)</deviceName>
    <manufacturerName>Triplex International Biosciences (China) Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001097</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C011936</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:26:54.023Z</lastUpdated>
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    <udiDi>06942293581849</udiDi>
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    <tradeName>Group A Streptococcus Antigen Rapid Test Kit</tradeName>
    <deviceName>Group A Streptococcus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11809</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:59.513Z</lastUpdated>
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    <tradeName>Group B Streptococcus Antigen Rapid Test Kit</tradeName>
    <deviceName>Group B Streptococcus Antigen Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11810</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:58.240Z</lastUpdated>
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    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-8112</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:05:18.585Z</lastUpdated>
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    <tradeName>Finecare</tradeName>
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    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-24T08:07:00.671Z</lastUpdated>
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    <tradeName>VitaPCR Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000023414</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCRAE0107</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:33:19.239Z</lastUpdated>
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