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    <tradeName>AIA-PACK DETECTOR STANDARDIZATION TEST CUP</tradeName>
    <deviceName>AIA-PACK DETECTOR STANDARDIZATION TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020970</reference>
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    <lastUpdated>2026-07-01T20:56:55.744Z</lastUpdated>
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    <tradeName>CL AIA-PACK DILUENT CONCENTRATE</tradeName>
    <deviceName>CL AIA-PACK DILUENT CONCENTRATE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029704</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:11.476Z</lastUpdated>
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    <tradeName>TSKgel GR01</tradeName>
    <deviceName>TSKgel GR01</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
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    <reference>0024755</reference>
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    <lastUpdated>2026-07-01T20:54:09.904Z</lastUpdated>
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    <basicUdiDi>45601892100040057P</basicUdiDi>
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    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0023295</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:09.499Z</lastUpdated>
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    <udiDi>04562185396904</udiDi>
    <basicUdiDi>45601892100040047M</basicUdiDi>
    <tradeName>Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400</tradeName>
    <deviceName>Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL2400</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0023650</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:08.271Z</lastUpdated>
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    <udiDi>04562185395594</udiDi>
    <basicUdiDi>45601892100010046Y</basicUdiDi>
    <tradeName>CL AIA-PACK WASH CONCENTRATE</tradeName>
    <deviceName>CL AIA-PACK WASH CONCENTRATE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029703</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:06.673Z</lastUpdated>
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    <basicUdiDi>45601892100010036W</basicUdiDi>
    <tradeName>CL AIA-PACK SUBSTRATE SET</tradeName>
    <deviceName>CL AIA-PACK SUBSTRATE SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029701</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:05.074Z</lastUpdated>
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    <basicUdiDi>456018921000200477</basicUdiDi>
    <tradeName>TRCR TIP SET</tradeName>
    <deviceName>TRCR TIP SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>PIPETTES, TIPS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0056301</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:04.273Z</lastUpdated>
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    <udiDi>04562185395297</udiDi>
    <basicUdiDi>456018921000200375</basicUdiDi>
    <tradeName>TRCR Purification Kit</tradeName>
    <deviceName>TRCR Purification Kit</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0056201</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:03.481Z</lastUpdated>
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    <udiDi>04562185395259</udiDi>
    <basicUdiDi>45601892100040037K</basicUdiDi>
    <tradeName>Automated TRCR Real-time Monitor TRCReady-80</tradeName>
    <deviceName>Automated TRCR Real-time Monitor TRCReady-80</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0023950</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:54:01.872Z</lastUpdated>
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    <udiDi>04560189283992</udiDi>
    <basicUdiDi>45601892100040017F</basicUdiDi>
    <tradeName>AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900</tradeName>
    <deviceName>AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0022930</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:59.429Z</lastUpdated>
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    <udiDi>04560189238794</udiDi>
    <basicUdiDi>45601892100040027H</basicUdiDi>
    <tradeName>290 Sample Loader	G8-290SL</tradeName>
    <deviceName>Tosoh Automated Glycohemoglobin Analyzer HLC-723G8</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0021562</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:52:58.540Z</lastUpdated>
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    <udiDi>04560189282896</udiDi>
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    <tradeName>AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360</tradeName>
    <deviceName>AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0019945</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:50:24.000Z</lastUpdated>
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    <udiDi>04560189238787</udiDi>
    <basicUdiDi>45601892100040027H</basicUdiDi>
    <tradeName>90 Sample Loader 	G8-90SL</tradeName>
    <deviceName>Tosoh Automated Glycohemoglobin Analyzer HLC-723G8</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0021561</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:50:23.193Z</lastUpdated>
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    <tradeName>CL AIA-PACK SUBSTRATE SET</tradeName>
    <deviceName>CL AIA-PACK SUBSTRATE SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029709</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:50:07.927Z</lastUpdated>
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    <tradeName>CL AIA-PACK DILUENT CONCENTRATE</tradeName>
    <deviceName>CL AIA-PACK DILUENT CONCENTRATE</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029708</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:50:07.139Z</lastUpdated>
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    <tradeName>AIA-PACK SUBSTRATE SET II</tradeName>
    <deviceName>AIA-PACK SUBSTRATE SET II</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020968</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:50:06.330Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0025233</reference>
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    <lastUpdated>2026-07-01T07:45:46.969Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0029408</reference>
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    <lastUpdated>2026-07-01T07:45:46.828Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
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    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0029174</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:45:46.631Z</lastUpdated>
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