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    <basicUdiDi>B-17402G2</basicUdiDi>
    <tradeName>SPOTCHEM D-00 (SD-9810)</tradeName>
    <deviceName>SPOTCHEM D-00 (SD-9810)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:17:09.188Z</lastUpdated>
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    <udiDi>D-105289MT</udiDi>
    <basicUdiDi>B-105289MT</basicUdiDi>
    <tradeName>SPOTCHEM D-03 SET</tradeName>
    <deviceName>SPOTCHEM D-03 SET</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105289</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:21.496Z</lastUpdated>
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    <udiDi>D-105287MP</udiDi>
    <basicUdiDi>B-105287MP</basicUdiDi>
    <tradeName>SPOTCHEM D-02 SET</tradeName>
    <deviceName>SPOTCHEM D-02 SET</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105287</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:17.466Z</lastUpdated>
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    <udiDi>D-105285MK</udiDi>
    <basicUdiDi>B-105285MK</basicUdiDi>
    <tradeName>SPOTCHEM D-01 SET</tradeName>
    <deviceName>SPOTCHEM D-01 SET</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:16.985Z</lastUpdated>
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    <udiDi>D-104933MU</udiDi>
    <basicUdiDi>B-104933MU</basicUdiDi>
    <tradeName>SPOTCHEM D-00 QR (SD-9811)</tradeName>
    <deviceName>SPOTCHEM D-00 QR (SD-9811)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>104933</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:27:02.269Z</lastUpdated>
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  <row>
    <udiDi>08033803510225</udiDi>
    <basicUdiDi>803380351BCAAM200DA0001YV</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 DA (44 Rgt Pos)  p/n 10997-01-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:01.509Z</lastUpdated>
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    <udiDi>08033803510263</udiDi>
    <basicUdiDi>803380351BCAAM200SA000173</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 SA (44 Rgt Pos) p/n 11025-01-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001202-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:51.001Z</lastUpdated>
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    <udiDi>08033803510386</udiDi>
    <basicUdiDi>803380351BCAAMIURADA001T4</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA DA (59 Smp Pos) p/n 10001-02-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3260011200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:47.982Z</lastUpdated>
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    <udiDi>6978918720164</udiDi>
    <basicUdiDi>697891872QES001WX</basicUdiDi>
    <tradeName>Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster Series)</tradeName>
    <deviceName>Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster Series)</deviceName>
    <manufacturerName>Xiamen Bioendo Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027676</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Qilin Endomaster Series</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:20:43.704Z</lastUpdated>
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    <udiDi>06978918720157</udiDi>
    <basicUdiDi>697891872PQS0012R</basicUdiDi>
    <tradeName>Intelligent Fully Automatic Endotoxin And MAT Detection Robot System (Phoenix Q Series)</tradeName>
    <deviceName>Intelligent fully automatic endotoxin and MAT detection robot system  (Phoenix Q series)</deviceName>
    <manufacturerName>Xiamen Bioendo Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027676</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Phoenix Q5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:15:44.850Z</lastUpdated>
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    <udiDi>06978669683107</udiDi>
    <basicUdiDi>697866968UKRT6D</basicUdiDi>
    <tradeName>Real-Time PCR Fluorescent Quantitative Analyzer</tradeName>
    <deviceName>Real-Time PCR Fluorescent Quantitative Analyzer</deviceName>
    <manufacturerName>Shenzhen Ukin Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055688</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>many</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:53:17.601Z</lastUpdated>
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  <row>
    <udiDi>06974795529975</udiDi>
    <basicUdiDi>697479552XPCAXE</basicUdiDi>
    <tradeName>Automatic Biochip Analyzer</tradeName>
    <deviceName>Automatic Biochip Analyzer</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XPCA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:29:21.131Z</lastUpdated>
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  <row>
    <udiDi>06978669683169</udiDi>
    <basicUdiDi>697866968UKRT6D</basicUdiDi>
    <tradeName>Real-Time PCR Fluorescent Quantitative Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Ukin Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055688</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UKRT Mini</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:43.611Z</lastUpdated>
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    <udiDi>06978669683329</udiDi>
    <basicUdiDi>697866968UKRT6D</basicUdiDi>
    <tradeName>Real-Time PCR Fluorescent Quantitative Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Ukin Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055688</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UKRT 320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:43.600Z</lastUpdated>
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    <udiDi>06978669683961</udiDi>
    <basicUdiDi>697866968UKRT6D</basicUdiDi>
    <tradeName>Real-Time PCR Fluorescent Quantitative Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Ukin Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055688</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UKRT 960</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:36:43.588Z</lastUpdated>
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