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    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260153</tradeName>
    <deviceName>NATtrol™ Chlamydia trachomatis Positive Control Pack</deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATLAC-6MC-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:55:46.951Z</lastUpdated>
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    <udiDi>01220000260146</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260146</tradeName>
    <deviceName>NATtrol™ Chlamydia trachomatis Positive Control Pack</deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATSAG-6MC-IVD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T04:49:05.678Z</lastUpdated>
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    <udiDi>D-697994388Fa037WQ94</udiDi>
    <basicUdiDi>B-697994388Fa037WQ94</basicUdiDi>
    <tradeName>D-697994388Fa037WQ94</tradeName>
    <deviceName>Group A Streptococcus Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011105</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:22:41.524Z</lastUpdated>
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    <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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    <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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    <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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    <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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    <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>08684387213295</udiDi>
    <basicUdiDi>B-08684387213295</basicUdiDi>
    <tradeName>RevoDx Streptococcus pneumoniae qPCR Kit</tradeName>
    <deviceName>RevoDx Streptococcus pneumoniae qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</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>IP202214-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:56:44.410Z</lastUpdated>
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    <udiDi>08683548258465</udiDi>
    <basicUdiDi>B-08683548258465</basicUdiDi>
    <tradeName>LyoSens Streptococcus Pneumoniae Detection qPCR Kit</tradeName>
    <deviceName>Streptococcus Pneumoniae Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</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>LYO35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:19:24.334Z</lastUpdated>
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