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    <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>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>4410700</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:10.902Z</lastUpdated>
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    <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>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <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>
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    <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>
    <legislation>IVDR 2017/746</legislation>
    <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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    <udiDi>10190302000185</udiDi>
    <basicUdiDi>01903024408258AX</basicUdiDi>
    <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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    <udiDi>10190302000147</udiDi>
    <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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    <udiDi>Not_app</udiDi>
    <basicUdiDi>++G143TC8ReactionTubeWS</basicUdiDi>
    <tradeName>T-COR 8 Reaction Tube</tradeName>
    <deviceName>T-COR 8 Reaction Tube</deviceName>
    <manufacturerName>Tetracore INC</manufacturerName>
    <manufacturerSrn>US-MF-000023064</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>TC-5029-500</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:39:28.811Z</lastUpdated>
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    <udiDi>D-442835PY</udiDi>
    <basicUdiDi>B-442835PY</basicUdiDi>
    <tradeName>SYNCHRON UDR Kit (12-pack)</tradeName>
    <deviceName>SYNCHRON UDR Kit (12-pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442835</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:19.597Z</lastUpdated>
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    <udiDi>08809740940155</udiDi>
    <basicUdiDi>880974094ACC01EB</basicUdiDi>
    <tradeName>G_PCR Chip Case</tradeName>
    <deviceName>G_PCR Chip Case</deviceName>
    <manufacturerName>OPTOLANE Technologies Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026042</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</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>CTG01-04</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:00:09.960Z</lastUpdated>
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    <udiDi>80575074300234</udiDi>
    <basicUdiDi>805750743HYCTHN</basicUdiDi>
    <tradeName>CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE</tradeName>
    <deviceName>CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE</deviceName>
    <manufacturerName>Hyris Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000031635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>HyCT16.01-25</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:48:58.023Z</lastUpdated>
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    <udiDi>07622283013121</udiDi>
    <basicUdiDi>7622283ULPDx7A</basicUdiDi>
    <tradeName>SOPHiA GENETICS™ Dx Universal Library Prep</tradeName>
    <deviceName>SOPHiA GENETICS™ Dx Universal Library Prep</deviceName>
    <manufacturerName>SOPHiA GENETICS SA</manufacturerName>
    <manufacturerSrn>CH-MF-000025221</manufacturerSrn>
    <authorisedRepresentativeName>SOPHiA GENETICS SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000022214</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>BX6002UNICMDL30</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:08:44.846Z</lastUpdated>
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    <tradeName>06978704661121</tradeName>
    <deviceName>Deep well plate</deviceName>
    <manufacturerName>Suzhou Acumen Biomedical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038603</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220001-1</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:39.419Z</lastUpdated>
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    <tradeName>YJSeq 300 Dx Sequencing Kit</tradeName>
    <deviceName>YJSeq 300 Dx Sequencing Kit</deviceName>
    <manufacturerName>Shanghai YJMED BioTechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055692</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>YJSeq 300 Dx Sequencing Kit</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:26:29.922Z</lastUpdated>
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    <tradeName>Magnetic Rod Sleeve</tradeName>
    <deviceName>Magnetic Rod Sleeve</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
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    <lastUpdated>2026-07-02T16:19:13.171Z</lastUpdated>
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    <tradeName>Microfluidic Chip</tradeName>
    <deviceName>Microfluidic Chip</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
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    <lastUpdated>2026-07-02T16:19:04.352Z</lastUpdated>
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    <tradeName>Magnetic Bead Nucleic Acid Extraction Kit</tradeName>
    <deviceName>Magnetic Bead Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Zhuhai Shineway Biotech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000027278</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <reference>NAEM-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:40:38.885Z</lastUpdated>
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    <tradeName>POP-6™ Polymer Dx (960 Samples)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>POP-7™ Polymer Dx (960 Samples)</tradeName>
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    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
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    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
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    <manufacturerName>Life Technologies Holdings Pte Ltd</manufacturerName>
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