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    <tradeName>Fluorocell RET</tradeName>
    <deviceName>Fluorocell RET</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010102</emdnCode>
    <emdnDescription>SPECIFIC RETICULOCYTE REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BN-337-547</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:07:21.743Z</lastUpdated>
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    <udiDi>14987562508959</udiDi>
    <basicUdiDi>4987562FLUOROCELLPLTWX</basicUdiDi>
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    <deviceName>FLUOROCELL PLT</deviceName>
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    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010103</emdnCode>
    <emdnDescription>COMPLETE CELL COUNT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-01T22:07:19.350Z</lastUpdated>
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    <udiDi>04987562422920</udiDi>
    <basicUdiDi>4987562CELLPACKDSTZ9</basicUdiDi>
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    <deviceName>CELLPACK DST</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
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    <lastUpdated>2026-07-01T22:04:26.166Z</lastUpdated>
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    <udiDi>00664369000509</udiDi>
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    <deviceName>Lysercell WDF</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZA900001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:30.068Z</lastUpdated>
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    <udiDi>00664369000073</udiDi>
    <basicUdiDi>4987562CELLPACKDCLX9</basicUdiDi>
    <tradeName>00664369000073</tradeName>
    <deviceName>CELLPACK DCL</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>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCL-300A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:02:29.260Z</lastUpdated>
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    <udiDi>03770028922314</udiDi>
    <basicUdiDi>3770028922OX58L0003ZF</basicUdiDi>
    <tradeName>LYA-3 Lyse 580.1</tradeName>
    <deviceName>LYA-3</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX58L0010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:36.780Z</lastUpdated>
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    <udiDi>03770028922307</udiDi>
    <basicUdiDi>3770028922OX58L0002ZD</basicUdiDi>
    <tradeName>LYA-2 Lyse 580.51</tradeName>
    <deviceName>LYA-2</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX58L0051</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:35.971Z</lastUpdated>
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    <basicUdiDi>3770028922OX58L0001ZB</basicUdiDi>
    <tradeName>LYA-1 Lyse 580.5</tradeName>
    <deviceName>LYA-1</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX58L0050</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:31.172Z</lastUpdated>
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    <udiDi>03770028922284</udiDi>
    <basicUdiDi>3770028922OX58D2000WX</basicUdiDi>
    <tradeName>DIL-A Diluent 580.20</tradeName>
    <deviceName>DIL-A Diluent 580.20</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX58D2000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:30.380Z</lastUpdated>
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    <udiDi>03770028922208</udiDi>
    <basicUdiDi>3770028922OX56L0002YK</basicUdiDi>
    <tradeName>LYC-2 Lyse 560.5</tradeName>
    <deviceName>LYC-2 Lyse 560</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX56L0050</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:29.586Z</lastUpdated>
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    <udiDi>03770028922192</udiDi>
    <basicUdiDi>3770028922OX56L0001YH</basicUdiDi>
    <tradeName>LYC-1 Lyse 560.2</tradeName>
    <deviceName>LYC-1 Lyse 560</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX56L0020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:28.780Z</lastUpdated>
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    <udiDi>03770028922185</udiDi>
    <basicUdiDi>3770028922OX56D2000W5</basicUdiDi>
    <tradeName>DIL-C Diluent 560.20</tradeName>
    <deviceName>DIL-C Diluent 560.20</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX56D2000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:12:24.772Z</lastUpdated>
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    <udiDi>03770028922277</udiDi>
    <basicUdiDi>3770028922OR50T0020VD</basicUdiDi>
    <tradeName>Stain RET</tradeName>
    <deviceName>Stain RET</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010102</emdnCode>
    <emdnDescription>SPECIFIC RETICULOCYTE REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR50T0020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:33.127Z</lastUpdated>
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    <udiDi>03770028922253</udiDi>
    <basicUdiDi>3770028922OR50S2000VA</basicUdiDi>
    <tradeName>Sheath 20 RET</tradeName>
    <deviceName>Sheath 20 RET</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR50S2000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:31.486Z</lastUpdated>
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    <udiDi>03770028922246</udiDi>
    <basicUdiDi>3770028922OR50C2000PS</basicUdiDi>
    <tradeName>Detergent 20 RET</tradeName>
    <deviceName>Detergent 20 RET</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR50C2000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:29.083Z</lastUpdated>
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    <udiDi>03770028922239</udiDi>
    <basicUdiDi>3770028922OR50L1000SN</basicUdiDi>
    <tradeName>Lyse 1 RET</tradeName>
    <deviceName>Lyse 1 RET</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR50L1000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:27.505Z</lastUpdated>
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    <udiDi>03770028922222</udiDi>
    <basicUdiDi>3770028922OR50D2000Q5</basicUdiDi>
    <tradeName>Diluent 20 RET</tradeName>
    <deviceName>Diluent 20 RET</deviceName>
    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR50D2000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:26.721Z</lastUpdated>
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    <udiDi>03770028922215</udiDi>
    <basicUdiDi>3770028922OX50C0005T8</basicUdiDi>
    <tradeName>CLE-P Cleanser 500.05</tradeName>
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    <manufacturerName>GMT SARL</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX50C0005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:25.092Z</lastUpdated>
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    <tradeName>Probe Cleaner 360.01</tradeName>
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    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX36C0100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:22.686Z</lastUpdated>
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    <manufacturerName>GMT SARL</manufacturerName>
    <manufacturerSrn>FR-MF-000025248</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OX36C0200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:10:18.700Z</lastUpdated>
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