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    <udiDi>05425030420003</udiDi>
    <basicUdiDi>5425030421031R6</basicUdiDi>
    <tradeName>i-Track 10 Wash Solution</tradeName>
    <deviceName>IDS-iSYS Wash Solution (Wash S)</deviceName>
    <manufacturerName>Immunodiagnostic Systems SA</manufacturerName>
    <manufacturerSrn>BE-MF-000015341</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD IS-CW100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:44.216Z</lastUpdated>
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    <udiDi>05425023685013</udiDi>
    <basicUdiDi>5425023685013VU</basicUdiDi>
    <tradeName>BLUESCAN1/ BlueScan Scanner + DR DOT LIC4/ Dr Dot Software</tradeName>
    <deviceName>BlueScan/DrDot Software</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>BLUESCAN1 + DR DOT LIC4</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:14.249Z</lastUpdated>
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    <udiDi>05425023685006</udiDi>
    <basicUdiDi>5425023685006VX</basicUdiDi>
    <tradeName>BlueDiver Instrument</tradeName>
    <deviceName>BlueDiver Instrument I</deviceName>
    <manufacturerName>D-tek s.a.</manufacturerName>
    <manufacturerSrn>BE-MF-000024530</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>BLUEDIVER1</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:02.087Z</lastUpdated>
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    <udiDi>05404035100356</udiDi>
    <basicUdiDi>54040351CY008-WSXQ</basicUdiDi>
    <tradeName>Cleaning solution</tradeName>
    <deviceName>Washing Solutions for CYANExpert 130</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY008-WS-III</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:58:52.061Z</lastUpdated>
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  <row>
    <udiDi>04562185380033</udiDi>
    <basicUdiDi>5430000495000020955MW</basicUdiDi>
    <tradeName>AIA-PACK WASH CONCENTRATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020955</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:57:50.411Z</lastUpdated>
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    <udiDi>04562185380026</udiDi>
    <basicUdiDi>5430000495000020956MY</basicUdiDi>
    <tradeName>AIA-PACK DILUENT CONCENTRATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
    <manufacturerSrn>BE-MF-000000210</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020956</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:57:49.623Z</lastUpdated>
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  <row>
    <udiDi>05404035100592</udiDi>
    <basicUdiDi>54040351CY0155X</basicUdiDi>
    <tradeName>CYANElite 290 Maintenance kit</tradeName>
    <deviceName>CYANElite 290</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY015-MIBTR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:50:39.729Z</lastUpdated>
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    <udiDi>05404035100400</udiDi>
    <basicUdiDi>54040351CY0145V</basicUdiDi>
    <tradeName>CYANVision Maintenance kit</tradeName>
    <deviceName>CYANVision</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY014-MIBTR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:50:34.127Z</lastUpdated>
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  <row>
    <udiDi>05404035100349</udiDi>
    <basicUdiDi>54040351CY008-WSXQ</basicUdiDi>
    <tradeName>Water preservation solution</tradeName>
    <deviceName>Washing Solutions for CYANExpert 130</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY008-WS-II</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:50:31.729Z</lastUpdated>
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  <row>
    <udiDi>05404035100417</udiDi>
    <basicUdiDi>54040351CY015-WSXE</basicUdiDi>
    <tradeName>CYANElite 290 Washing Solution</tradeName>
    <deviceName>CYANElite 290 Washing Solution</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY015-WS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:07.608Z</lastUpdated>
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  <row>
    <udiDi>05404035100332</udiDi>
    <basicUdiDi>54040351CY008-WSXQ</basicUdiDi>
    <tradeName>Rinse solution</tradeName>
    <deviceName>Washing Solutions for CYANExpert 130</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY005/8-WS-I</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:03.604Z</lastUpdated>
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  <row>
    <udiDi>05404035100325</udiDi>
    <basicUdiDi>54040351CY0015L</basicUdiDi>
    <tradeName>Washing solution</tradeName>
    <deviceName>Washing solution</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY001-WS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:46:01.999Z</lastUpdated>
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  <row>
    <udiDi>05404035100295</udiDi>
    <basicUdiDi>54040351CY0155X</basicUdiDi>
    <tradeName>CYANElite 290</tradeName>
    <deviceName>CYANElite 290</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY015</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:45:59.606Z</lastUpdated>
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  <row>
    <udiDi>05404035100288</udiDi>
    <basicUdiDi>54040351CY0145V</basicUdiDi>
    <tradeName>CYANVision</tradeName>
    <deviceName>CYANVision</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02010199</emdnCode>
    <emdnDescription>CHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CY014</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:45:57.209Z</lastUpdated>
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    <udiDi>15065023763907</udiDi>
    <basicUdiDi>5065023763TA10001RC</basicUdiDi>
    <tradeName>TruAna</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA10001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:43.795Z</lastUpdated>
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    <udiDi>15065023763884</udiDi>
    <basicUdiDi>5065023763TR10001Y9</basicUdiDi>
    <tradeName>TruReno</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR10001</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:42.225Z</lastUpdated>
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    <udiDi>15065023763877</udiDi>
    <basicUdiDi>5065023763TL10001VT</basicUdiDi>
    <tradeName>TruLyta</tradeName>
    <deviceName>Electrolyte Analyzer</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TL10001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:41.373Z</lastUpdated>
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    <udiDi>15065023763815</udiDi>
    <basicUdiDi>5065023763TX100VT</basicUdiDi>
    <tradeName>TruOx</tradeName>
    <deviceName>Blood Gas Analyzer</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TX10001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:34.965Z</lastUpdated>
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    <udiDi>15065023763785</udiDi>
    <basicUdiDi>5065023763TG100S4</basicUdiDi>
    <tradeName>TruGlyc</tradeName>
    <deviceName>HbA1c Analyzer</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TG10001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:34.167Z</lastUpdated>
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    <udiDi>15065023763396</udiDi>
    <basicUdiDi>5065023763TV100VD</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Immunofluorescence Analyzer</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>TV20001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:22:33.368Z</lastUpdated>
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