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    <udiDi>00815381020031</udiDi>
    <basicUdiDi>357302BUDI000020SG</basicUdiDi>
    <tradeName>FilmArray® 2.0 Instrument</tradeName>
    <deviceName>FilmArray® 2.0 Instrument</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FLM2-ASY-0001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:34:46.779Z</lastUpdated>
  </row>
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    <udiDi>00815381021007</udiDi>
    <basicUdiDi>357302BUDI002231TD</basicUdiDi>
    <tradeName>BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel</tradeName>
    <deviceName>BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070506</emdnCode>
    <emdnDescription>TROPICAL FEVER - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>424803</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:23.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815381020369</udiDi>
    <basicUdiDi>357302BUDI000917U8</basicUdiDi>
    <tradeName>SpotFire®</tradeName>
    <deviceName>SpotFire®</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FAST-ASY-0002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:22.539Z</lastUpdated>
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  <row>
    <udiDi>00815381020338</udiDi>
    <basicUdiDi>357302BUDI000001SC</basicUdiDi>
    <tradeName>BioFire® Blood Culture Identification 2 (BCID2) Panel</tradeName>
    <deviceName>BioFire® Blood Culture Identification 2 (BCID2) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0147</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:21.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815381020208</udiDi>
    <basicUdiDi>357302BUDI000006SN</basicUdiDi>
    <tradeName>BioFire® Joint Infection (JI) Panel</tradeName>
    <deviceName>BioFire® Joint Infection (JI) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0135</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:20.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815381020123</udiDi>
    <basicUdiDi>357302BUDI000004SJ</basicUdiDi>
    <tradeName>FilmArray® Meningitis/Encephalitis (ME) Panel</tradeName>
    <deviceName>FilmArray® Meningitis/Encephalitis (ME) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0118</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:04.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815381020116</udiDi>
    <basicUdiDi>357302BUDI000005SL</basicUdiDi>
    <tradeName>FilmArray® Gastrointestinal (GI) Panel</tradeName>
    <deviceName>FilmArray® Gastrointestinal (GI) Panel</deviceName>
    <manufacturerName>BioFire Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003311</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFIT-ASY-0104</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:04.078Z</lastUpdated>
  </row>
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