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    <tradeName>VIASURE Bordetella Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-BDT196TE</reference>
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    <udiDi>08435440222095</udiDi>
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    <tradeName>VIASURE Bordetella Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
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    <udiDi>08435440222101</udiDi>
    <basicUdiDi>84354402_MDXRESPB_BDT4F</basicUdiDi>
    <tradeName>VIASURE Bordetella Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
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    <udiDi>08435440212195</udiDi>
    <basicUdiDi>84354402_MDXRESPB_BDT4F</basicUdiDi>
    <tradeName>VIASURE Bordetella Real Time PCR Detection Kit</tradeName>
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    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-17T19:37:53.375Z</lastUpdated>
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    <udiDi>D-697994388Fa038WS9D</udiDi>
    <basicUdiDi>B-697994388Fa038WS9D</basicUdiDi>
    <tradeName>D-697994388Fa038WS9D</tradeName>
    <deviceName>Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence, Unvaccinated)</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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:22:43.706Z</lastUpdated>
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    <udiDi>D-697994388Fa014WC7B</udiDi>
    <basicUdiDi>B-697994388Fa014WC7B</basicUdiDi>
    <tradeName>D-697994388Fa014WC7B</tradeName>
    <deviceName>Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fa014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:19:22.569Z</lastUpdated>
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    <udiDi>D-EBX-001-UNFK</udiDi>
    <basicUdiDi>B-EBX-001-UNFK</basicUdiDi>
    <tradeName>EurobioPlex Bordetella pertussis et parapertussis</tradeName>
    <deviceName>EurobioPlex Bordetella pertussis et parapertussis</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-001-UN</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:27:12.544Z</lastUpdated>
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    <udiDi>D-EBX-001-24AT</udiDi>
    <basicUdiDi>B-EBX-001-24AT</basicUdiDi>
    <tradeName>EurobioPlex Bordetella pertussis et parapertussis</tradeName>
    <deviceName>EurobioPlex Bartonella pertussis et parapertussis</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-001-24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:27:10.937Z</lastUpdated>
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    <udiDi>D-EBX-001-48B9</udiDi>
    <basicUdiDi>B-EBX-001-48B9</basicUdiDi>
    <tradeName>EurobioPlex Bordetella pertussis et parapertussis</tradeName>
    <deviceName>EurobioPlex Bartonella pertussis et parapertussis</deviceName>
    <manufacturerName>Eurobio Scientific</manufacturerName>
    <manufacturerSrn>FR-MF-000011745</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBX-001-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:27:08.537Z</lastUpdated>
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    <udiDi>D-888501395GBBordVC</udiDi>
    <basicUdiDi>B-888501395GBBordVC</basicUdiDi>
    <tradeName>Great Basin Bordetella Direct Test</tradeName>
    <deviceName>Great Basin Bordetella Direct 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300782</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:29:33.054Z</lastUpdated>
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    <udiDi>D-81649002ABPTS02JB59</udiDi>
    <basicUdiDi>B-81649002ABPTS02JB59</basicUdiDi>
    <tradeName>D-81649002ABPTS02JB59</tradeName>
    <deviceName>Bordetella Pertussis Detection Kit (Fluorescence PCR)</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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABPTS02-AHG48E/ ABPTS02-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:22.276Z</lastUpdated>
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    <udiDi>08685115801012</udiDi>
    <basicUdiDi>B-08685115801012</basicUdiDi>
    <tradeName>LyoSens Bordetella pertussis qPCR Kit</tradeName>
    <deviceName>Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO52</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:24.464Z</lastUpdated>
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    <udiDi>08684387212670</udiDi>
    <basicUdiDi>B-08684387212670</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis/parapertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis/parapertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202331-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:19.635Z</lastUpdated>
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    <udiDi>08684387212663</udiDi>
    <basicUdiDi>B-08684387212663</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis/parapertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis/parapertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202331-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:18.805Z</lastUpdated>
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    <udiDi>08684387212656</udiDi>
    <basicUdiDi>B-08684387212656</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202330-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:18.004Z</lastUpdated>
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    <udiDi>08684387212649</udiDi>
    <basicUdiDi>B-08684387212649</basicUdiDi>
    <tradeName>RevoDx Bordetella pertussis qPCR Kit</tradeName>
    <deviceName>RevoDx Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202330-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:54:17.203Z</lastUpdated>
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    <udiDi>08683548257789</udiDi>
    <basicUdiDi>B-08683548257789</basicUdiDi>
    <tradeName>ChainFor Bordetella pertussis Detection qPCR Kit</tradeName>
    <deviceName>Bordetella pertussis 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>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:17:00.083Z</lastUpdated>
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    <tradeName>TaqPath™ Menu | GeneProof™ Bordetella pertussis/parapertussis PCR Kit</tradeName>
    <deviceName>GeneProof Bordetella pertussis/parapertussis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58208</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:23.159Z</lastUpdated>
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    <udiDi>08594161952497</udiDi>
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    <tradeName>GeneProof Bordetella pertussis/parapertussis PCR Kit</tradeName>
    <deviceName>GeneProof Bordetella pertussis/parapertussis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP/ISEX/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:15.259Z</lastUpdated>
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    <basicUdiDi>B-08594161952473</basicUdiDi>
    <tradeName>GeneProof Bordetella pertussis/parapertussis PCR Kit</tradeName>
    <deviceName>GeneProof Bordetella pertussis/parapertussis PCR Kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105011607</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP/ISEX/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:48:14.461Z</lastUpdated>
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