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<eudamedExport entity="devices">
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    <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>
  <row>
    <udiDi>03573026629908</udiDi>
    <basicUdiDi>357302BUDI002283TY</basicUdiDi>
    <tradeName>VITEK® 2 AST-N429</tradeName>
    <deviceName>VITEK® 2 AST-N429</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>543226</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:34.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026162375</udiDi>
    <basicUdiDi>357302BUDI000223SY</basicUdiDi>
    <tradeName>VITEK® 2 XL BLUE MOD COLORM</tradeName>
    <deviceName>VITEK® 2 XL BLUE MOD COLORM</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>27227</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:29.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026162351</udiDi>
    <basicUdiDi>357302BUDI000221SU</basicUdiDi>
    <tradeName>VITEK® 2 60 BLUE MOD COLORM</tradeName>
    <deviceName>VITEK® 2 60 BLUE MOD COLORM</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27225</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:43:27.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026530846</udiDi>
    <basicUdiDi>357302BUDI000456TR</basicUdiDi>
    <tradeName>VITEK® 2 AST-GN13</tradeName>
    <deviceName>VITEK® 2 AST-GN13</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080107</emdnCode>
    <emdnDescription>GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308212</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:15.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026529994</udiDi>
    <basicUdiDi>357302BUDI000877UM</basicUdiDi>
    <tradeName>VITEK® 2 GP</tradeName>
    <deviceName>VITEK® 2 GP</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080103</emdnCode>
    <emdnDescription>GRAM POSITIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:15.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026529987</udiDi>
    <basicUdiDi>357302BUDI000045SY</basicUdiDi>
    <tradeName>VITEK® 2 GN</tradeName>
    <deviceName>VITEK® 2 GN</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080101</emdnCode>
    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308099</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:14.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026529727</udiDi>
    <basicUdiDi>357302BUDI000453TK</basicUdiDi>
    <tradeName>VITEK® 2 ANC</tradeName>
    <deviceName>VITEK® 2 ANC</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080105</emdnCode>
    <emdnDescription>ANAEROBIC AND OTHER PATHOGENIC GERMS IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308131</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:09.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026529710</udiDi>
    <basicUdiDi>357302BUDI000046T2</basicUdiDi>
    <tradeName>VITEK® 2 NH</tradeName>
    <deviceName>VITEK® 2 NH</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080101</emdnCode>
    <emdnDescription>GRAM NEGATIVE IDENTIFICATION - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308130</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:08.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026529697</udiDi>
    <basicUdiDi>357302BUDI000218T7</basicUdiDi>
    <tradeName>VITEK® 2 YST</tradeName>
    <deviceName>VITEK® 2 YST</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104030403</emdnCode>
    <emdnDescription>IDENTIFICATION SYSTEMS FOR YEASTS AND FUNGI - AUTOMATED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8308128</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:07.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026222222</udiDi>
    <basicUdiDi>357302BUDI002006T4</basicUdiDi>
    <tradeName>VITEK® 2 DENSICHEK® Plus Standards Kit</tradeName>
    <deviceName>VITEK® 2 DENSICHEK® Plus Standards Kit</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21255</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:07.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026220624</udiDi>
    <basicUdiDi>357302BUDI000560TM</basicUdiDi>
    <tradeName>VITEK® 2 COMPACT</tradeName>
    <deviceName>VITEK® 2 COMPACT</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27415</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:03.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026162382</udiDi>
    <basicUdiDi>357302BUDI000224T2</basicUdiDi>
    <tradeName>VITEK® 2 XL BLUE MOD COLORM 220V</tradeName>
    <deviceName>VITEK® 2 XL BLUE MOD COLORM 220V</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27228</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:02.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026162368</udiDi>
    <basicUdiDi>357302BUDI000222SW</basicUdiDi>
    <tradeName>VITEK® 2 60 BLUE MOD COLORM 220V</tradeName>
    <deviceName>VITEK® 2 60 BLUE MOD COLORM 220V</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010180</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27226</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:01.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026147167</udiDi>
    <basicUdiDi>357302BUDI000559U4</basicUdiDi>
    <tradeName>SMART CARRIER STATION</tradeName>
    <deviceName>SMART CARRIER STATION</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27209</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:46:00.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026049782</udiDi>
    <basicUdiDi>357302BUDI000044SW</basicUdiDi>
    <tradeName>VITEK® 2 Pipetter/Diluter Accessories Kit</tradeName>
    <deviceName>VITEK® 2 Pipetter/Diluter Accessories Kit</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0203010185</emdnCode>
    <emdnDescription>ANTIBIOTIC SUSCEPTIBILITY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21219</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:45:55.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026049591</udiDi>
    <basicUdiDi>357302BUDI000895UP</basicUdiDi>
    <tradeName>BACT/ALERT® 3D RIGHT INCUBATION MODULE</tradeName>
    <deviceName>BACT/ALERT® 3D RIGHT INCUBATION MODULE</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210161</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:45:55.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026049577</udiDi>
    <basicUdiDi>357302BUDI000141SV</basicUdiDi>
    <tradeName>BACT/ALERT® 3D LEFT INCUBATION MODULE</tradeName>
    <deviceName>BACT/ALERT® 3D LEFT INCUBATION MODULE</deviceName>
    <manufacturerName>bioMérieux, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011802</manufacturerSrn>
    <authorisedRepresentativeName>bioMérieux SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000004435</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02030201</emdnCode>
    <emdnDescription>AUTOMATED BLOOD CULTURE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210159</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T21:45:54.232Z</lastUpdated>
  </row>
</eudamedExport>