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    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
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    <tradeName>Cuvette (heparin)</tradeName>
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    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
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    <tradeName>Reaction Cuvette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biolis Medical Corp.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <tradeName>Cup &amp; Pin pro</tradeName>
    <deviceName>Cup &amp; Pin pro</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>200011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:24.234Z</lastUpdated>
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    <udiDi>03610230008492</udiDi>
    <basicUdiDi>361023ymz_g_cuvettesCX</basicUdiDi>
    <tradeName>Yumizen G Cuvettes</tradeName>
    <deviceName>Yumizen G Cuvettes</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1300036425</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:17:05.389Z</lastUpdated>
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    <udiDi>03610230006719</udiDi>
    <basicUdiDi>361023sample_cup7S</basicUdiDi>
    <tradeName>SAMPLE CUP - GREEN</tradeName>
    <deviceName>SAMPLE CUP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0503010280</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01766</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:16:56.592Z</lastUpdated>
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    <udiDi>03610230006702</udiDi>
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    <tradeName>SAMPLE CUP - BLUE</tradeName>
    <deviceName>SAMPLE CUP</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES</emdnDescription>
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    <reference>A11A01765</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:15:26.480Z</lastUpdated>
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    <udiDi>03610230005644</udiDi>
    <basicUdiDi>361023cuvette_rackPM</basicUdiDi>
    <tradeName>CUVETTES RACK PENTRA C200</tradeName>
    <deviceName>CUVETTES RACK PENTRA C200</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01914</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:12:36.966Z</lastUpdated>
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    <udiDi>03610230005583</udiDi>
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    <tradeName>CUVETTE SEGMENTS</tradeName>
    <deviceName>CUVETTE SEGMENTS</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A11A01891</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:12:34.946Z</lastUpdated>
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  <row>
    <udiDi>03607360092163</udiDi>
    <basicUdiDi>3607369216BUEY</basicUdiDi>
    <tradeName>A1C/CE LOW VOLUME SAMPLE COLLECTION TUBE</tradeName>
    <deviceName>A1C/CE LOW VOLUME SAMPLE COLLECTION TUBE</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301020280</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9216</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:49.988Z</lastUpdated>
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    <udiDi>03607360092149</udiDi>
    <basicUdiDi>3607369214BUEN</basicUdiDi>
    <tradeName>TEST TUBES (200)</tradeName>
    <deviceName>TEST TUBES (200)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301020180</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9214</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:49.197Z</lastUpdated>
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    <udiDi>03607360092026</udiDi>
    <basicUdiDi>3607369202BUE5</basicUdiDi>
    <tradeName>TUBES AND CAPS FOR CONTROLS (20)</tradeName>
    <deviceName>TUBES AND CAPS FOR CONTROLS (20)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301020180</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9202</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:41.191Z</lastUpdated>
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    <udiDi>03607360092019</udiDi>
    <basicUdiDi>3607369201BUDY</basicUdiDi>
    <tradeName>MICRO TUBES 1 mL (110)</tradeName>
    <deviceName>MICRO TUBES 1 mL (110)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301020280</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9201</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:37.205Z</lastUpdated>
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    <udiDi>03607360092002</udiDi>
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    <tradeName>DIALYSIS SYSTEM (24)</tradeName>
    <deviceName>DIALYSIS SYSTEM (24)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301020180</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC TUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:36.382Z</lastUpdated>
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    <udiDi>03607360043981</udiDi>
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    <tradeName>18 WELLS ANTISERA SEGMENT (10)</tradeName>
    <deviceName>18 WELLS ANTISERA SEGMENT (10)</deviceName>
    <manufacturerName>sebia</manufacturerName>
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    <emdnCode>W0503010280</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4398</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:16.395Z</lastUpdated>
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    <lastUpdated>2026-07-30T18:09:00.308Z</lastUpdated>
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    <udiDi>03607360025826</udiDi>
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    <tradeName>CAPI 3 REAGENT CUPS (24 x 14)</tradeName>
    <deviceName>CAPI 3 REAGENT CUPS (24 x 14)</deviceName>
    <manufacturerName>sebia</manufacturerName>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2582</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:08:42.701Z</lastUpdated>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES</emdnDescription>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:08:38.707Z</lastUpdated>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:08:34.701Z</lastUpdated>
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    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2083</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:08:28.301Z</lastUpdated>
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