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    <tradeName>Alethia</tradeName>
    <deviceName>Alethia</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>610189</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:24:50.321Z</lastUpdated>
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    <udiDi>G763I190007TM0</udiDi>
    <basicUdiDi>++G763I190007TM3C</basicUdiDi>
    <tradeName>SAMBA III Tablet Module</tradeName>
    <deviceName>SAMBA III Tablet Module</deviceName>
    <manufacturerName>Diagnostics for the Real World (Europe) Ltd.</manufacturerName>
    <manufacturerSrn>UK-MF-000047660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>I190007TM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:35:39.813Z</lastUpdated>
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    <udiDi>++G763I190007AM0</udiDi>
    <basicUdiDi>++G763I190007AMZG</basicUdiDi>
    <tradeName>SAMBA III Assay Module</tradeName>
    <deviceName>SAMBA III Assay Module</deviceName>
    <manufacturerName>Diagnostics for the Real World (Europe) Ltd.</manufacturerName>
    <manufacturerSrn>UK-MF-000047660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>I190007AM</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:30:22.749Z</lastUpdated>
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    <udiDi>04660014360505</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4M1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTPRIME4M1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:14.252Z</lastUpdated>
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    <udiDi>04660014362370</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4М3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTPRIME4M3-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:13.264Z</lastUpdated>
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    <udiDi>04660014362387</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4М6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTPRIME4M6-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:11.768Z</lastUpdated>
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    <udiDi>04660014362417</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 5М3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTPRIME5M3-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:09.865Z</lastUpdated>
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    <udiDi>04660014362424</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 5М6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTPRIME5M6-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:48.303Z</lastUpdated>
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    <udiDi>04660014362363</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 4Х1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTPRIME4Х1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:47.633Z</lastUpdated>
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    <udiDi>04660014362400</udiDi>
    <basicUdiDi>466001436DA02ZN</basicUdiDi>
    <tradeName>Real-time PCR instrument DTprime 5Х1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTPRIME5Х1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:43.555Z</lastUpdated>
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  <row>
    <udiDi>04660014360529</udiDi>
    <basicUdiDi>466001436DA01ZL</basicUdiDi>
    <tradeName>Real-time PCR instrument DTlite 5S1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>O-DTLITE5S1-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:47:28.551Z</lastUpdated>
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    <udiDi>D-81649002MNAP01JGSA</udiDi>
    <basicUdiDi>B-81649002MNAP01JGSA</basicUdiDi>
    <tradeName>D-81649002MNAP01JGSA</tradeName>
    <deviceName>HG-N32 Nucleic Acid Purification System</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MNAP01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:17.742Z</lastUpdated>
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    <udiDi>04660014366330</udiDi>
    <basicUdiDi>466001436DA03ZQ</basicUdiDi>
    <tradeName>DTstream 9L4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-DTstream9L4-A-EU</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.506Z</lastUpdated>
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    <udiDi>04660014366347</udiDi>
    <basicUdiDi>466001436DA03ZQ</basicUdiDi>
    <tradeName>DTstream 12L1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-DTstream12L1-A-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.471Z</lastUpdated>
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    <udiDi>04660014366354</udiDi>
    <basicUdiDi>466001436DA03ZQ</basicUdiDi>
    <tradeName>DTstream 12L4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-DTstream12L4-A-EU</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.437Z</lastUpdated>
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    <udiDi>04660014366361</udiDi>
    <basicUdiDi>466001436DA03ZQ</basicUdiDi>
    <tradeName>DTstream 15L1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-DTstream15L1-A-EU</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.416Z</lastUpdated>
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    <udiDi>04660014366378</udiDi>
    <basicUdiDi>466001436DA03ZQ</basicUdiDi>
    <tradeName>DTstream 15L4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-DTstream15L4-A-EU</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.395Z</lastUpdated>
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    <udiDi>04660014366385</udiDi>
    <basicUdiDi>466001436DA03ZQ</basicUdiDi>
    <tradeName>DTstream 9М1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-DTstream9М1-A-EU</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.374Z</lastUpdated>
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    <basicUdiDi>466001436DA03ZQ</basicUdiDi>
    <tradeName>DTstream 9М4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
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    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O-DTstream9М4-A-EU</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.349Z</lastUpdated>
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    <tradeName>DTstream 12М1</tradeName>
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    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:00:28.312Z</lastUpdated>
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