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    <basicUdiDi>B-07332940000127FC</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® GBS</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GXGBS-100N-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:14:18.857Z</lastUpdated>
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    <udiDi>07332940007898</udiDi>
    <basicUdiDi>B-07332940007898</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® BCR-ABL Ultra p190</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBCRABLP190-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:20.841Z</lastUpdated>
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    <udiDi>07332940006297</udiDi>
    <basicUdiDi>B-07332940006297</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Xpress Strep A</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011103</emdnCode>
    <emdnDescription>STREP. A DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XPRSTREPA-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:20.044Z</lastUpdated>
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    <udiDi>07332940001834</udiDi>
    <basicUdiDi>B-07332940001834</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBCRABL-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:06:19.246Z</lastUpdated>
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    <udiDi>07332940001865</udiDi>
    <basicUdiDi>081164701-XPERTCHECK-3B</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XPERTCHECK-CE-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.795Z</lastUpdated>
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    <udiDi>07332940002305</udiDi>
    <basicUdiDi>081164701-GXUTR-2L</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXUTR-CE-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.776Z</lastUpdated>
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    <udiDi>07332940002558</udiDi>
    <basicUdiDi>081164701-SWAB/A-3H</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWAB/A-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.757Z</lastUpdated>
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  <row>
    <udiDi>07332940002954</udiDi>
    <basicUdiDi>081164701-URINE/A-LG</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URINE/A-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.719Z</lastUpdated>
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    <udiDi>07332940006013</udiDi>
    <basicUdiDi>081164701-GXFFPE-LYSIS-MP</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXFFPE-LYSIS-CE-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.699Z</lastUpdated>
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    <udiDi>07332940007003</udiDi>
    <basicUdiDi>081164701-SWAB/G-43</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWAB/G-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.657Z</lastUpdated>
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  <row>
    <udiDi>07332940007683</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert II (GX-II)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.642Z</lastUpdated>
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  <row>
    <udiDi>07332940007690</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert IV (GX-IV)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007706</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert XVI (GX-XVI)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007713</udiDi>
    <basicUdiDi>081164701-INFINITY-ZH</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GX-INFINITY 48S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.590Z</lastUpdated>
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  <row>
    <udiDi>07332940007720</udiDi>
    <basicUdiDi>081164701-INFINITY-ZH</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GX-INFINITY 80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.566Z</lastUpdated>
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    <udiDi>07332940009687</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert XVI-RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.507Z</lastUpdated>
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    <udiDi>07332940009694</udiDi>
    <basicUdiDi>081164701-GX-X5</basicUdiDi>
    <tradeName>GeneXpert®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GeneXpert IV (GX-IV)-RS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:31:10.477Z</lastUpdated>
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