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    <tradeName>NOVEOS® Immunoassay System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.033Z</lastUpdated>
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    <udiDi>00816879023046</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Wash Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.020Z</lastUpdated>
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    <udiDi>00816879023053</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Probe Wash Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63170</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.001Z</lastUpdated>
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    <udiDi>00816879023091</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Substrate Mix Container</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>118877-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.982Z</lastUpdated>
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    <udiDi>00816879023107</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Optics Tips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>119844-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.960Z</lastUpdated>
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    <udiDi>00816879023114</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Cuvette Arcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>117450-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.941Z</lastUpdated>
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  <row>
    <udiDi>00816879023138</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Accuracy and Precision Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>530005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.922Z</lastUpdated>
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  <row>
    <udiDi>00816879023169</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Cuvette Wash Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.905Z</lastUpdated>
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    <udiDi>00816879028003</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Sample Dilution Cups</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>123322-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.892Z</lastUpdated>
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    <udiDi>00816879028560</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Caps for 5 mL Tubes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>137533-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.877Z</lastUpdated>
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  <row>
    <udiDi>00816879028768</udiDi>
    <basicUdiDi>081687902NOVINST37</basicUdiDi>
    <tradeName>NOVEOS flex Immunoassay System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX64000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.857Z</lastUpdated>
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    <udiDi>00816879028775</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Substrate Mix Container Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX64006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.835Z</lastUpdated>
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    <udiDi>00816879028782</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Cuvette Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX64007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.815Z</lastUpdated>
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    <udiDi>00816879028805</udiDi>
    <basicUdiDi>081687902NOVACCKX</basicUdiDi>
    <tradeName>Anti-evaporation Caps</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hycor Biomedical LLC</manufacturerName>
    <manufacturerSrn>US-MF-000031449</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FX64009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:54.791Z</lastUpdated>
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