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    <deviceName>Gene Amplification Detector</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <reference>CP437283</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:53.359Z</lastUpdated>
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    <deviceName>GeneStream System</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W02050180</emdnCode>
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    <reference>MHGS01A</reference>
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    <lastUpdated>2026-07-17T01:18:27.330Z</lastUpdated>
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    <udiDi>00382904431594</udiDi>
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    <tradeName>Not Applicable</tradeName>
    <deviceName>BD Pre-warm Heater</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
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    <lastUpdated>2026-07-15T20:34:39.068Z</lastUpdated>
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    <basicUdiDi>038290OAEMHDBH32</basicUdiDi>
    <tradeName>Not Applicable</tradeName>
    <deviceName>BD PREWARM HEATER</deviceName>
    <manufacturerName>Becton, Dickinson and Company</manufacturerName>
    <manufacturerSrn>US-MF-000018910</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>442950</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:34:33.440Z</lastUpdated>
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    <udiDi>None</udiDi>
    <basicUdiDi>++G143TC8MagneticMixerY5</basicUdiDi>
    <tradeName>T-COR 8 Magnetic Mixer</tradeName>
    <deviceName>T-COR 8 Magnetic Mixer</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>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC-5018-001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:39:28.019Z</lastUpdated>
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    <udiDi>D-81649002MRQP06PN4S</udiDi>
    <basicUdiDi>B-81649002MRQP06PN4S</basicUdiDi>
    <tradeName>D-81649002MRQP06PN4S</tradeName>
    <deviceName>HG-P320 Real-time PCR 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>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRQP06-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:20.136Z</lastUpdated>
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    <udiDi>D-81649002MRQP04PJ48</udiDi>
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    <deviceName>HG-P960 Real-time PCR system</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRQP04-E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:05:19.333Z</lastUpdated>
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    <tradeName>bCUBE 2.0</tradeName>
    <deviceName>bCUBE 2.0</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>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>bCUBE 2.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:48:55.623Z</lastUpdated>
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    <udiDi>06975760470131</udiDi>
    <basicUdiDi>697576047RS32S3</basicUdiDi>
    <tradeName>06975760470131</tradeName>
    <deviceName>RS32 All In One Digital PCR System</deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS3204 , RS3205, RS3206, RS3207</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:45:01.897Z</lastUpdated>
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    <udiDi>06438147387700</udiDi>
    <basicUdiDi>6438147EonisQ_4J</basicUdiDi>
    <tradeName>Eonis Q96</tradeName>
    <deviceName>Eonis Q96</deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2044-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:04:19.888Z</lastUpdated>
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    <udiDi>04053228028031</udiDi>
    <basicUdiDi>4053228IHCSSHAKER0000013S</basicUdiDi>
    <tradeName>Hybrid Capture System Rotary Shaker 1</tradeName>
    <deviceName>Hybrid Capture System Rotary Shaker 1</deviceName>
    <manufacturerName>QIAGEN Sciences LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014502</manufacturerSrn>
    <authorisedRepresentativeName>QIAGEN GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004971</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000-2240E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:23:04.307Z</lastUpdated>
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