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    <deviceName>Anti-Thyroglobulin (Anti-Tg) ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <reference>CAN-ATG-4150</reference>
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    <deviceName>Β2-Microglobulin ELISA Kit</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <emdnDescription>BETA2-MICROGLOBULIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <deviceName>Adiponectin ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-++B261CANALD500K6</basicUdiDi>
    <tradeName>++B261CANALD500K6</tradeName>
    <deviceName>Aldosterone ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-ALD-500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:25.621Z</lastUpdated>
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    <udiDi>++B261CANAD208CQ</udiDi>
    <basicUdiDi>B-++B261CANAD208CQ</basicUdiDi>
    <tradeName>++B261CANAD208CQ</tradeName>
    <deviceName>Androstenedione ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050101</emdnCode>
    <emdnDescription>ANDROSTENEDIONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-AD-208</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:24.026Z</lastUpdated>
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    <udiDi>09120131770038</udiDi>
    <basicUdiDi>912013177xPOCCartS4</basicUdiDi>
    <tradeName>xPOC Cartridge</tradeName>
    <deviceName>xPOC Cartridge</deviceName>
    <manufacturerName>GENSPEED Biotech</manufacturerName>
    <manufacturerSrn>AT-MF-000013008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSPC2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:42:38.604Z</lastUpdated>
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    <udiDi>09120131770021</udiDi>
    <basicUdiDi>912013177VitaminD3CJ</basicUdiDi>
    <tradeName>Vitamin D xPOC</tradeName>
    <deviceName>Vitamin D xPOC</deviceName>
    <manufacturerName>GENSPEED Biotech</manufacturerName>
    <manufacturerSrn>AT-MF-000013008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IATK215</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:42:37.802Z</lastUpdated>
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    <udiDi>09120122925072</udiDi>
    <basicUdiDi>9120122925076R</basicUdiDi>
    <tradeName>09120122925072</tradeName>
    <deviceName>Stop Solution</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00-5007-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:30.688Z</lastUpdated>
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    <basicUdiDi>9120122925036H</basicUdiDi>
    <tradeName>09120122925034</tradeName>
    <deviceName>Washing Solution 4x conc.</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00-5003-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:26.684Z</lastUpdated>
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    <udiDi>09120122923009</udiDi>
    <basicUdiDi>91201229230JV</basicUdiDi>
    <tradeName>09120122923009</tradeName>
    <deviceName>ConfigXplorer</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152299</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-0100-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:25.891Z</lastUpdated>
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    <udiDi>09120122920756</udiDi>
    <basicUdiDi>91201229207K2</basicUdiDi>
    <tradeName>09120122920756</tradeName>
    <deviceName>ALEX Food</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07-5001-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:18.684Z</lastUpdated>
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    <udiDi>09120122920657</udiDi>
    <basicUdiDi>91201229206JY</basicUdiDi>
    <tradeName>09120122920657</tradeName>
    <deviceName>ALEX Air</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-5001-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:17.877Z</lastUpdated>
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    <tradeName>09120122920329</tradeName>
    <deviceName>ALEX³ Allergy Xplorer</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-2001-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:13.882Z</lastUpdated>
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    <tradeName>09120122920220</tradeName>
    <deviceName>ALEX² Allergy Xplorer</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020205</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SCREEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-2001-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:13.077Z</lastUpdated>
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    <tradeName>femSense</tradeName>
    <deviceName>femSense</deviceName>
    <manufacturerName>SteadySense GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000003984</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09120095900052</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:39:16.519Z</lastUpdated>
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    <tradeName>OvuFind</tradeName>
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    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OVFRPD-01                                                  OVFRPD-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:32.974Z</lastUpdated>
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    <tradeName>Boditech PSA Control</tradeName>
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    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152005</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPO-250</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:54.714Z</lastUpdated>
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    <tradeName>AFIAS Total βhCG</tradeName>
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    <manufacturerName>Boditech Med Inc.</manufacturerName>
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    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-3</reference>
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    <lastUpdated>2026-07-31T21:00:53.878Z</lastUpdated>
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    <tradeName>ichroma™ Total IgE</tradeName>
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    <manufacturerName>Boditech Med Inc.</manufacturerName>
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    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-91</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:50.801Z</lastUpdated>
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    <tradeName>AFIAS Microalbumin</tradeName>
    <deviceName>AFIAS Microalbumin</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-30</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:49.353Z</lastUpdated>
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