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    <tradeName>RevoDx Klebsiella pneumonia qPCR Kit</tradeName>
    <deviceName>RevoDx Klebsiella pneumonia 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>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202203-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:56:17.683Z</lastUpdated>
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    <udiDi>08684387213196</udiDi>
    <basicUdiDi>B-08684387213196</basicUdiDi>
    <tradeName>RevoDx Pseudomonas aeruginosa qPCR Kit</tradeName>
    <deviceName>RevoDx Pseudomonas aeruginosa 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>
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    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202202-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:56:15.012Z</lastUpdated>
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    <udiDi>08684387211529</udiDi>
    <basicUdiDi>B-08684387211529</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>
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    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202201-12</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:50:43.283Z</lastUpdated>
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    <udiDi>08684387211512</udiDi>
    <basicUdiDi>B-08684387211512</basicUdiDi>
    <tradeName>RevoDx Sepsis Pathogen PLUS Detection Kit</tradeName>
    <deviceName>RevoDx Sepsis Pathogen PLUS 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>IP202470-24</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:50:42.483Z</lastUpdated>
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    <udiDi>08684387211505</udiDi>
    <basicUdiDi>B-08684387211505</basicUdiDi>
    <tradeName>RevoDx Sepsis Pathogen PLUS Detection Kit</tradeName>
    <deviceName>RevoDx Sepsis Pathogen PLUS 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>IP202470-12</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:50:38.477Z</lastUpdated>
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    <udiDi>08684387210638</udiDi>
    <basicUdiDi>B-08684387210638</basicUdiDi>
    <tradeName>RevoDx Sepsis Pathogen PLUS Detection Kit</tradeName>
    <deviceName>RevoDx Sepsis Pathogen PLUS 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>IP202470-48</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:47:42.178Z</lastUpdated>
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    <udiDi>08683548259783</udiDi>
    <basicUdiDi>B-08683548259783</basicUdiDi>
    <tradeName>LyoSens Gardnerella vaginalis Detection qPCR Kit</tradeName>
    <deviceName>Gardnerella vaginalis 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>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO57</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:21:25.398Z</lastUpdated>
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    <udiDi>08683548257222</udiDi>
    <basicUdiDi>B-08683548257222</basicUdiDi>
    <tradeName>ChainFor Wound ID-30 Genotyping qPCR Kit</tradeName>
    <deviceName>Wound ID-30 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>CFP17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:15:10.799Z</lastUpdated>
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    <udiDi>08683548257215</udiDi>
    <basicUdiDi>B-08683548257215</basicUdiDi>
    <tradeName>ChainFor Vaginosis ID-30 Genotyping qPCR Kit</tradeName>
    <deviceName>Vaginosis ID-30 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>CFP15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:15:08.735Z</lastUpdated>
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    <udiDi>08683548256911</udiDi>
    <basicUdiDi>B-08683548256911</basicUdiDi>
    <tradeName>ChainFor UTI ID-27 Genotyping qPCR Kit</tradeName>
    <deviceName>UTI ID-27 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>CFP16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:14:43.898Z</lastUpdated>
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    <udiDi>06975578360204</udiDi>
    <basicUdiDi>B-06975578360204</basicUdiDi>
    <tradeName>06975578360204</tradeName>
    <deviceName>Four Bacteria Combined Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>2000265</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:14.607Z</lastUpdated>
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    <udiDi>06975578360198</udiDi>
    <basicUdiDi>B-06975578360198</basicUdiDi>
    <tradeName>06975578360198</tradeName>
    <deviceName>Five Streptococcus Species Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>2000264</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:12.183Z</lastUpdated>
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    <udiDi>06975578360167</udiDi>
    <basicUdiDi>B-06975578360167</basicUdiDi>
    <tradeName>06975578360167</tradeName>
    <deviceName>Six Candida Species Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000261</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:09.782Z</lastUpdated>
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    <udiDi>06974854620438</udiDi>
    <basicUdiDi>B-06974854620438</basicUdiDi>
    <tradeName>Candida albicans，Trichomonas vaginalis，Gardnerella Antigen combined Test Kit</tradeName>
    <deviceName>Candida albicans，Trichomonas vaginalis，Gardnerella Antigen combined Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070203</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2200125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:32.035Z</lastUpdated>
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    <udiDi>06974795550597</udiDi>
    <basicUdiDi>B-06974795550597</basicUdiDi>
    <tradeName>06974795550597</tradeName>
    <deviceName>Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210109B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:27.554Z</lastUpdated>
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    <udiDi>06974795550580</udiDi>
    <basicUdiDi>B-06974795550580</basicUdiDi>
    <tradeName>06974795550580</tradeName>
    <deviceName>Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR  Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210109A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:26.749Z</lastUpdated>
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    <udiDi>06974795550573</udiDi>
    <basicUdiDi>B-06974795550573</basicUdiDi>
    <tradeName>06974795550573</tradeName>
    <deviceName>Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210107B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:22.763Z</lastUpdated>
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    <udiDi>06974795550566</udiDi>
    <basicUdiDi>B-06974795550566</basicUdiDi>
    <tradeName>06974795550566</tradeName>
    <deviceName>Carbapenem-resistant Gene Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210107A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:21.146Z</lastUpdated>
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    <udiDi>06974795550559</udiDi>
    <basicUdiDi>B-06974795550559</basicUdiDi>
    <tradeName>06974795550559</tradeName>
    <deviceName>Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210105B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:20.940Z</lastUpdated>
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    <udiDi>06974795550542</udiDi>
    <basicUdiDi>B-06974795550542</basicUdiDi>
    <tradeName>06974795550542</tradeName>
    <deviceName>Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent  PCR Method)</deviceName>
    <manufacturerName>RocGene (Xuzhou) Technology Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000024511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10210105A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:46:20.312Z</lastUpdated>
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