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    <deviceName>Streptococcus pneumoniae Nucleic Acid Detection Kit (Fluorescence)</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
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    <tradeName>GenomEra® GBS Assay Kit</tradeName>
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    <tradeName>GenomEra GBS Assay Kit</tradeName>
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    <manufacturerName>Uniogen Oy</manufacturerName>
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    <tradeName>GenomEra® GBS Assay Kit</tradeName>
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    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>GenomEra GBS Assay Kit</tradeName>
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    <manufacturerName>Uniogen Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032341</manufacturerSrn>
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    <udiDi>D-81649002CGBS01AC2NU</udiDi>
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    <tradeName>D-81649002CGBS01AC2NU</tradeName>
    <deviceName>GeneStream GBS Assay</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>GeneStream GBS Controls</deviceName>
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    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>RevoDx MRSA qPCR Kit</tradeName>
    <deviceName>RevoDx MRSA qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202266-100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:37.360Z</lastUpdated>
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    <basicUdiDi>B-08684387214384</basicUdiDi>
    <tradeName>RevoDx MRSA qPCR Kit</tradeName>
    <deviceName>RevoDx MRSA qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202266-25</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:33.868Z</lastUpdated>
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    <udiDi>08684387213264</udiDi>
    <basicUdiDi>B-08684387213264</basicUdiDi>
    <tradeName>RevoDx Staphyloccocus spp. qPCR Kit</tradeName>
    <deviceName>RevoDx Staphyloccocus spp. qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202209-500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:56:38.013Z</lastUpdated>
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    <udiDi>08684387213257</udiDi>
    <basicUdiDi>B-08684387213257</basicUdiDi>
    <tradeName>RevoDx Staphyloccocus aureus qPCR Kit</tradeName>
    <deviceName>RevoDx Staphyloccocus aureus qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202208-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:56:36.866Z</lastUpdated>
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    <udiDi>08684387212892</udiDi>
    <basicUdiDi>B-08684387212892</basicUdiDi>
    <tradeName>RevoDx Streptococcus pneumoniae / pyogenes / agalactiae qPCR Kit</tradeName>
    <deviceName>RevoDx Streptococcus pneumoniae / pyogenes / agalactiae qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202427-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:55:08.488Z</lastUpdated>
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    <udiDi>08683548257635</udiDi>
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    <tradeName>ChainFor 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>W0105011102</emdnCode>
    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:16:43.546Z</lastUpdated>
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    <tradeName>06972221450503</tradeName>
    <deviceName>Respiratory Pathogens Nucleic Acid Detection Kit (Isothermal Amplification on Disk Chip)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:19.003Z</lastUpdated>
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    <udiDi>06971042228889</udiDi>
    <basicUdiDi>B-06971042228889</basicUdiDi>
    <tradeName>Streptococcus Suis Real Time PCR Kit</tradeName>
    <deviceName>Streptococcus Suis Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZD-0069-02</reference>
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    <tradeName>Group B Streptococcus (GBS)  Real Time PCR Kit</tradeName>
    <deviceName>Group B Streptococcus (GBS)  Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
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    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-0237-02</reference>
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    <lastUpdated>2026-07-06T08:59:58.223Z</lastUpdated>
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    <tradeName>Group A Streptococcus (GAS) Real Time PCR Kit</tradeName>
    <deviceName>Group A Streptococcus (GAS) Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
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    <tradeName>Streptococcus Pneumoniae Real Time PCR Kit</tradeName>
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    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-0146-02</reference>
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    <tradeName>Streptococcus Pyogenes Real Time PCR Kit</tradeName>
    <deviceName>Streptococcus Pyogenes Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD-0059-02</reference>
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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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    <emdnDescription>STREPTOCOCCAL  DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG191032</reference>
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    <lastUpdated>2026-07-06T00:42:27.198Z</lastUpdated>
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