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    <tradeName>Uni-medica Fluorescent Immunoanalyzer</tradeName>
    <deviceName>Automatic Nucleic Acid System</deviceName>
    <manufacturerName>Shenzhen Uni-medica Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000022946</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UM-IF 100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:29:04.036Z</lastUpdated>
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    <udiDi>06974473303712</udiDi>
    <basicUdiDi>697447330HC10HD</basicUdiDi>
    <tradeName>HC-10 Portable Colloidal Gold Immunoassay Analyzer</tradeName>
    <deviceName>HC-10 Portable Colloidal Gold Immunoassay Analyzer</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020280</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:16:22.100Z</lastUpdated>
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    <tradeName>Colloidal Gold Reader</tradeName>
    <deviceName>Colloidal Gold Reader</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>GIA100</reference>
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    <lastUpdated>2026-07-02T12:57:55.056Z</lastUpdated>
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    <udiDi>06974402559012</udiDi>
    <basicUdiDi>697440255INST_VIRTUOSO6E</basicUdiDi>
    <tradeName>Automatic Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Automatic Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Virtue Diagnostics (Suzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013251</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11000002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:57:54.287Z</lastUpdated>
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    <udiDi>06974312710008</udiDi>
    <basicUdiDi>697431271MEYU</basicUdiDi>
    <tradeName>Fully Automatic ELISA Analyzer</tradeName>
    <deviceName>Fully Automatic ELISA Analyzer</deviceName>
    <manufacturerName>Changsha Imadek Intelligent Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042852</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010299</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME-1000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:50:50.532Z</lastUpdated>
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    <udiDi>06974201150762</udiDi>
    <basicUdiDi>697420115YQ001DZ</basicUdiDi>
    <tradeName>POCLia8</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Taizhou Zecen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050486</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Chemiluminescence Immunoassay Analyzer</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:39:00.602Z</lastUpdated>
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    <udiDi>06974183540872</udiDi>
    <basicUdiDi>697418354A07NT</basicUdiDi>
    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A07</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:03.717Z</lastUpdated>
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    <basicUdiDi>697418354A06NR</basicUdiDi>
    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A06</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:38:02.926Z</lastUpdated>
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    <udiDi>06974183540841</udiDi>
    <basicUdiDi>697418354A05NP</basicUdiDi>
    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A05</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:58.918Z</lastUpdated>
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    <udiDi>06974183540834</udiDi>
    <basicUdiDi>697418354A08NV</basicUdiDi>
    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A08</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:58.110Z</lastUpdated>
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    <udiDi>06974183540292</udiDi>
    <basicUdiDi>697418354A02NH</basicUdiDi>
    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:57.323Z</lastUpdated>
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    <udiDi>06974183540216</udiDi>
    <basicUdiDi>697418354A01NF</basicUdiDi>
    <tradeName>Automated Chemiluminescent Immunoassay Analyzing System</tradeName>
    <deviceName>Automated Chemiluminescent Immunoassay Analyzing System</deviceName>
    <manufacturerName>Sophonix Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000021894</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:37:56.522Z</lastUpdated>
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    <udiDi>06974081870736</udiDi>
    <basicUdiDi>697408187FluoreMiniL4</basicUdiDi>
    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>SINGUWAY BIOTECH INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000027180</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FluoreMini</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:26:09.116Z</lastUpdated>
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    <udiDi>06974071231059</udiDi>
    <basicUdiDi>697407123PalmFX4</basicUdiDi>
    <tradeName>06974071231059</tradeName>
    <deviceName>Palm F Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Shijiazhuang Hipro Biotechnology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002171</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Palm F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:24:41.807Z</lastUpdated>
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    <basicUdiDi>697407123HP-AFS/1QG</basicUdiDi>
    <tradeName>06974071231011</tradeName>
    <deviceName>HP-AFS/1 Automatic Immunoassay System</deviceName>
    <manufacturerName>Shijiazhuang Hipro Biotechnology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000002171</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-AFS/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:24:40.987Z</lastUpdated>
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    <udiDi>06974062230160</udiDi>
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    <tradeName>06974062230160</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Hunan Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020269</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG0054</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:21:00.829Z</lastUpdated>
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    <tradeName>Automatic Hybrid Capture System</tradeName>
    <deviceName>Automatic Hybrid Capture System</deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>Humiss Beratung GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000023447</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>HB-104C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:08:55.025Z</lastUpdated>
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    <basicUdiDi>697387314SACVC</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Hangzhou Dalton BioSciences, Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036196</manufacturerSrn>
    <authorisedRepresentativeName>Humiss Beratung GmbH</authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput &gt; 700 test/h)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>CS-SA301C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:08:54.224Z</lastUpdated>
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    <tradeName>06973864382923</tradeName>
    <deviceName>LiCA Homogeneous Chemiluminescence System (LiCA System)</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04090115300</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:05:51.533Z</lastUpdated>
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    <deviceName>LiCA Homogeneous Chemiluminescence System (LiCA System)</deviceName>
    <manufacturerName>Chemclin Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009729</manufacturerSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04090113000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:05:42.726Z</lastUpdated>
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