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    <tradeName>Ethyl Glucuronide 500 Semi-Quantitative Calibrators Set</tradeName>
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    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09976558190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>Fentanyl Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CONTROLS FOR NARCOTICS / TOXICOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Fentanyl II Enzyme Immunoassay</tradeName>
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    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>BOND-ADVANCE Terminal (7.0)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49.4525</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:27.683Z</lastUpdated>
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    <udiDi>09349458005535</udiDi>
    <basicUdiDi>9349458001D9</basicUdiDi>
    <tradeName>BOND-ADVANCE Controller (7.0)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49.4526</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:27.553Z</lastUpdated>
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    <udiDi>09349458005436</udiDi>
    <basicUdiDi>9349458001D9</basicUdiDi>
    <tradeName>BOND-PRIME ARC Refresh Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91.1592</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T03:39:27.475Z</lastUpdated>
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    <udiDi>09349458005504</udiDi>
    <basicUdiDi>9349458001D9</basicUdiDi>
    <tradeName>BOND System Control Kit (version 7)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>49.0644</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:25.428Z</lastUpdated>
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    <udiDi>09349458005511</udiDi>
    <basicUdiDi>9349458001D9</basicUdiDi>
    <tradeName>BOND Controller (7.0)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Melbourne Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000016740</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S49.4524</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:49:24.761Z</lastUpdated>
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    <udiDi>00816870020006</udiDi>
    <basicUdiDi>081687002IN010ZK</basicUdiDi>
    <tradeName>00816870020006</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:13.638Z</lastUpdated>
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    <udiDi>00816870020013</udiDi>
    <basicUdiDi>081687002IN00823</basicUdiDi>
    <tradeName>00816870020013</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:13.617Z</lastUpdated>
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    <udiDi>00816870020044</udiDi>
    <basicUdiDi>081687002IN002ZL</basicUdiDi>
    <tradeName>Monobind</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:13.600Z</lastUpdated>
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    <udiDi>00816870020051</udiDi>
    <basicUdiDi>081687002IN00925</basicUdiDi>
    <tradeName>00816870020051</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:13.585Z</lastUpdated>
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    <udiDi>00816870020068</udiDi>
    <basicUdiDi>081687002IN013ZR</basicUdiDi>
    <tradeName>00816870020068</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:13.564Z</lastUpdated>
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    <udiDi>00816870020075</udiDi>
    <basicUdiDi>081687002IN006ZU</basicUdiDi>
    <tradeName>00816870020075</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</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>IN006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:45:13.547Z</lastUpdated>
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    <udiDi>00816870020082</udiDi>
    <basicUdiDi>081687002IN006-2UP</basicUdiDi>
    <tradeName>00816870020082</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</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>IN006-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.545Z</lastUpdated>
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    <udiDi>00816870020426</udiDi>
    <basicUdiDi>081687002PSAVAST842522</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuBind VAST ELISA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8425-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.530Z</lastUpdated>
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    <udiDi>00816870020433</udiDi>
    <basicUdiDi>081687002PSAVAST842522</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuBind VAST ELISA Kit - 480 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8425-300D</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.519Z</lastUpdated>
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    <basicUdiDi>081687002PSAVAST842522</basicUdiDi>
    <tradeName>AFP, CEA &amp; PSA AccuBind VAST ELISA Kit - 960 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EARLY PROSTATE CANCER ANTIGEN - 2</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8425-300E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.500Z</lastUpdated>
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    <udiDi>00816870020471</udiDi>
    <basicUdiDi>081687002CA1253025PQ</basicUdiDi>
    <tradeName>CA-125 AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025-300A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.485Z</lastUpdated>
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    <udiDi>00816870020488</udiDi>
    <basicUdiDi>081687002CA1253025PQ</basicUdiDi>
    <tradeName>CA-125 AccuBind ELISA Kit - 192 wells</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3025-300B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:44:55.465Z</lastUpdated>
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