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    <udiDi>09343044006913</udiDi>
    <basicUdiDi>B-09343044006913</basicUdiDi>
    <tradeName>RIDA®Plex Vaginitis and Vaginosis 8 well Step 1</tradeName>
    <deviceName>RIDA®Plex Vaginitis and Vaginosis 8 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27117S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:46:14.104Z</lastUpdated>
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    <udiDi>09343044006906</udiDi>
    <basicUdiDi>B-09343044006906</basicUdiDi>
    <tradeName>RIDA®Plex Vaginitis and Vaginosis 8 well Step 2</tradeName>
    <deviceName>RIDA®Plex Vaginitis and Vaginosis 8 well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>R-Biopharm AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050025</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27117P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:46:13.383Z</lastUpdated>
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    <udiDi>09343044003905</udiDi>
    <basicUdiDi>B-09343044003905</basicUdiDi>
    <tradeName>Vaginitis and vaginosis 12-well</tradeName>
    <deviceName>Step 1 tubes for Vaginitis and vaginosis 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87124S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:14.195Z</lastUpdated>
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    <udiDi>09343044003899</udiDi>
    <basicUdiDi>B-09343044003899</basicUdiDi>
    <tradeName>Vaginitis and vaginosis 12-well</tradeName>
    <deviceName>Step 2 Plates for Vaginitis and vaginosis 12-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>87124P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:43:13.340Z</lastUpdated>
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    <udiDi>09343044001994</udiDi>
    <basicUdiDi>B-09343044001994</basicUdiDi>
    <tradeName>Vaginitis and vaginosis 8-well</tradeName>
    <deviceName>Step 1 tubes for Vaginitis and vaginosis 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27117S</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:04.458Z</lastUpdated>
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  <row>
    <udiDi>09343044001987</udiDi>
    <basicUdiDi>B-09343044001987</basicUdiDi>
    <tradeName>Vaginitis and vaginosis 8-well</tradeName>
    <deviceName>Step 2 Plates for Vaginitis and vaginosis 8-well</deviceName>
    <manufacturerName>AusDiagnostics Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000020558</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>27117P</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:42:03.516Z</lastUpdated>
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    <udiDi>09309001216122</udiDi>
    <basicUdiDi>B-09309001216122</basicUdiDi>
    <tradeName>InfectID-BSI Bacterial and Yeast Combined Detection Kit</tradeName>
    <deviceName>InfectID-BSI Bacterial and Yeast Combined Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:39:46.553Z</lastUpdated>
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    <udiDi>09309001216115</udiDi>
    <basicUdiDi>B-09309001216115</basicUdiDi>
    <tradeName>InfectID-BSI Y3 Yeast Detection Kit</tradeName>
    <deviceName>InfectID-BSI Y3 Yeast Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1500</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:39:42.552Z</lastUpdated>
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  <row>
    <udiDi>09309001216108</udiDi>
    <basicUdiDi>B-09309001216108</basicUdiDi>
    <tradeName>InfectID-BSI Y2 Yeast Detection Kit</tradeName>
    <deviceName>InfectID-BSI Y2 Yeast Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:39:41.749Z</lastUpdated>
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  <row>
    <udiDi>09309001216092</udiDi>
    <basicUdiDi>B-09309001216092</basicUdiDi>
    <tradeName>InfectID-BSI Y1 Yeast Detection Kit</tradeName>
    <deviceName>InfectID-BSI Y1 Yeast Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:39:40.951Z</lastUpdated>
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  <row>
    <udiDi>09309001216085</udiDi>
    <basicUdiDi>B-09309001216085</basicUdiDi>
    <tradeName>InfectID-BSI B6 Bacterial Detection Kit</tradeName>
    <deviceName>InfectID-BSI B6 Bacterial Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:39:40.149Z</lastUpdated>
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  <row>
    <udiDi>09309001216078</udiDi>
    <basicUdiDi>B-09309001216078</basicUdiDi>
    <tradeName>InfectID-BSI B5 Bacterial Detection Kit</tradeName>
    <deviceName>InfectID-BSI B5 Bacterial Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB900</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:38:01.773Z</lastUpdated>
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  <row>
    <udiDi>09309001216061</udiDi>
    <basicUdiDi>B-09309001216061</basicUdiDi>
    <tradeName>InfectID-BSI B4 Bacterial Detection Kit</tradeName>
    <deviceName>InfectID-BSI B4 Bacterial Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB800</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:38:00.968Z</lastUpdated>
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  <row>
    <udiDi>09309001216054</udiDi>
    <basicUdiDi>B-09309001216054</basicUdiDi>
    <tradeName>InfectID-BSI B3 Bacterial Detection Kit</tradeName>
    <deviceName>InfectID-BSI B3 Bacterial Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB700</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:37:56.987Z</lastUpdated>
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    <udiDi>09309001216047</udiDi>
    <basicUdiDi>B-09309001216047</basicUdiDi>
    <tradeName>InfectID-BSI B2 Bacterial Detection Kit</tradeName>
    <deviceName>InfectID-BSI B2 Bacterial Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB600</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:37:56.221Z</lastUpdated>
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    <udiDi>09309001216030</udiDi>
    <basicUdiDi>B-09309001216030</basicUdiDi>
    <tradeName>InfectID-BSI B1 Bacterial Detection Kit</tradeName>
    <deviceName>InfectID-BSI B1 Bacterial Detection Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB500</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:37:55.411Z</lastUpdated>
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    <udiDi>09309001216016</udiDi>
    <basicUdiDi>B-09309001216016</basicUdiDi>
    <tradeName>InfectID-BSI Bacterial and Yeast Assay Kit</tradeName>
    <deviceName>InfectID-BSI Bacterial and Yeast Assay Kit</deviceName>
    <manufacturerName>Microbio Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033903</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRB1300.5</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:37:50.453Z</lastUpdated>
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    <udiDi>08684998279161</udiDi>
    <basicUdiDi>B-08684998279161</basicUdiDi>
    <tradeName>LyoSens UTI ID-26 Genotyping qPCR Kit</tradeName>
    <deviceName>UTI ID-26 Genotyping 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>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:21:59.639Z</lastUpdated>
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    <udiDi>08684387214315</udiDi>
    <basicUdiDi>B-08684387214315</basicUdiDi>
    <tradeName>RevoDx Sepsis Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Sepsis Pathogen Detection 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>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202201-48sh</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:26.149Z</lastUpdated>
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    <udiDi>08684387214308</udiDi>
    <basicUdiDi>B-08684387214308</basicUdiDi>
    <tradeName>RevoDx Sepsis Pathogen Detection Kit</tradeName>
    <deviceName>RevoDx Sepsis Pathogen Detection 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>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202201-48sl</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:01:07.688Z</lastUpdated>
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