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    <tradeName>DS-30 Matrix Standard Kit (Dye Set D) Dx</tradeName>
    <deviceName>Matrix Standards, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A35945</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:52.250Z</lastUpdated>
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    <udiDi>10190302005937</udiDi>
    <basicUdiDi>0190302TCF00005084L</basicUdiDi>
    <tradeName>3500 Dx Genetic Analyzer</tradeName>
    <deviceName>Applied Biosystems™ 3500 Dx/3500xL Dx Genetic Analyzers</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</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>4405182 (A27772)</reference>
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    <lastUpdated>2026-07-15T19:49:49.889Z</lastUpdated>
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    <udiDi>10190302000833</udiDi>
    <basicUdiDi>0190302A25511RB</basicUdiDi>
    <tradeName>Ion PGM™ Dx Sequencer</tradeName>
    <deviceName>Ion Personal Genome Machine (PGM™) Dx Instrument System</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>4485656</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:38.650Z</lastUpdated>
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    <udiDi>10190302000680</udiDi>
    <basicUdiDi>01903024462785CK</basicUdiDi>
    <tradeName>Polymer Pouch Caps, Dx</tradeName>
    <deviceName>Polymer Pouch Cap, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4462785</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:37.848Z</lastUpdated>
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    <udiDi>10190302000673</udiDi>
    <basicUdiDi>01903024462113AU</basicUdiDi>
    <tradeName>Sequencing Standard BigDye™ Terminator v1.1 Dx</tradeName>
    <deviceName>Sequencing Standard, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4462113</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:37.051Z</lastUpdated>
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    <udiDi>10190302000666</udiDi>
    <basicUdiDi>0190302TCF00005034A</basicUdiDi>
    <tradeName>Polymer Delivery Pump Cleaning Kit Dx</tradeName>
    <deviceName>Polymer Delivery Pump Cleaning Kit Dx, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4461875</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:36.250Z</lastUpdated>
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    <udiDi>10190302000444</udiDi>
    <basicUdiDi>0190302TCF0000576DAR</basicUdiDi>
    <tradeName>Array Card Spectral Calibration Dye Kit</tradeName>
    <deviceName>Array Card Kits, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432644</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:32.251Z</lastUpdated>
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    <udiDi>10190302000314</udiDi>
    <basicUdiDi>0190302TCF0000576AAK</basicUdiDi>
    <tradeName>384‑Well Region of Interest (ROI) and Background Plates</tradeName>
    <deviceName>Region of Interest (ROI) and Background Plates, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432482</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:31.446Z</lastUpdated>
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    <udiDi>10190302000284</udiDi>
    <basicUdiDi>0190302TCF0000576BAM</basicUdiDi>
    <tradeName>384-Well Spectral Calibration Plate with FAM Dye</tradeName>
    <deviceName>Spectral Calibration Plates, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432445</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:30.646Z</lastUpdated>
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    <udiDi>10190302000321</udiDi>
    <basicUdiDi>0190302TCF0000576CAP</basicUdiDi>
    <tradeName>RNase P 384-Well Instrument Verification Plate</tradeName>
    <deviceName>RNase P Instrument Verification Plates, a part of Calibration and Verification Plates</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050199</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4432500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:29.052Z</lastUpdated>
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    <udiDi>10190302000277</udiDi>
    <basicUdiDi>019030244107169T</basicUdiDi>
    <tradeName>Septa Cathode Buffer Container Dx</tradeName>
    <deviceName>Septa Cathode Buffer Container, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410716</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:13.301Z</lastUpdated>
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    <udiDi>10190302000260</udiDi>
    <basicUdiDi>019030244107009C</basicUdiDi>
    <tradeName>96-Well Septa Dx</tradeName>
    <deviceName>96-Well Septa, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410700</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:10.902Z</lastUpdated>
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    <udiDi>10190302000253</udiDi>
    <basicUdiDi>0190302441022797</basicUdiDi>
    <tradeName>3500 Dx Series 96-Well Standard Retainer &amp; Base Set</tradeName>
    <deviceName>96-Well/384-Well Standard Retainer and Base Set, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410227</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:09.306Z</lastUpdated>
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    <udiDi>10190302000246</udiDi>
    <basicUdiDi>01903024409543B8</basicUdiDi>
    <tradeName>Conditioning Reagent Dx</tradeName>
    <deviceName>Conditioning Reagent, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4409543</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:08.506Z</lastUpdated>
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    <udiDi>10190302000208</udiDi>
    <basicUdiDi>01903024404682AL</basicUdiDi>
    <tradeName>3500 Dx Capillary Array 50-cm</tradeName>
    <deviceName>Capillary Array 36-cm/50-cm, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4404684</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:06.903Z</lastUpdated>
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    <udiDi>10190302000192</udiDi>
    <basicUdiDi>019030244043079P</basicUdiDi>
    <tradeName>Hi-Di™ Formamide Dx (5 mL)</tradeName>
    <deviceName>Hi-Di™ Formamide, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4404307 (4440752)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:04.496Z</lastUpdated>
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    <tradeName>Anode Buffer Container Dx</tradeName>
    <deviceName>Buffer Container, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
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    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4393925</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:02.901Z</lastUpdated>
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    <basicUdiDi>01903024393709CW</basicUdiDi>
    <tradeName>POP-7™ Polymer Dx (384 Samples)</tradeName>
    <deviceName>POP™ polymer, a part of Genetic Analyzer Reagents and Consumables</deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000023931</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4393709</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:02.151Z</lastUpdated>
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    <basicUdiDi>008407331REVOGENECLA003TK</basicUdiDi>
    <tradeName>Revogene® Mock Pie</tradeName>
    <deviceName>Revogene® Mock Pie</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610208</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:25:04.711Z</lastUpdated>
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    <tradeName>Revogene®</tradeName>
    <deviceName>Revogene®</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
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    <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>610210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:25:03.944Z</lastUpdated>
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