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    <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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    <udiDi>06942293581849</udiDi>
    <basicUdiDi>697518250L118095G</basicUdiDi>
    <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>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <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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    <udiDi>06942293581832</udiDi>
    <basicUdiDi>697518250L118104Z</basicUdiDi>
    <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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    <udiDi>06933289829755</udiDi>
    <basicUdiDi>B-06933289829755</basicUdiDi>
    <tradeName>Finecare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WW11P0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:07:00.671Z</lastUpdated>
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    <udiDi>04260743471406</udiDi>
    <basicUdiDi>B-04260743471406</basicUdiDi>
    <tradeName>IDEAL Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3 10343T20-WOE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:14:28.231Z</lastUpdated>
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    <udiDi>04260743471383</udiDi>
    <basicUdiDi>B-04260743471383</basicUdiDi>
    <tradeName>TOP Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3 10343-MTU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:14:27.308Z</lastUpdated>
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  <row>
    <udiDi>04260743471345</udiDi>
    <basicUdiDi>B-04260743471345</basicUdiDi>
    <tradeName>Cleartest Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3 10343</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:14:26.413Z</lastUpdated>
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    <udiDi>04260743471338</udiDi>
    <basicUdiDi>B-04260743471338</basicUdiDi>
    <tradeName>TOP Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3 10343-20-MTU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:14:25.507Z</lastUpdated>
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    <udiDi>04260743471291</udiDi>
    <basicUdiDi>B-04260743471291</basicUdiDi>
    <tradeName>Cleartest Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C3 10343-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:14:24.633Z</lastUpdated>
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    <udiDi>04260743470546</udiDi>
    <basicUdiDi>B-04260743470546</basicUdiDi>
    <tradeName>VELLAP Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VELLAP Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000035636</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.13.6.6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:14:10.205Z</lastUpdated>
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