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    <deviceName>xPOC Cartridge</deviceName>
    <manufacturerName>GENSPEED Biotech</manufacturerName>
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    <tradeName>Vitamin D xPOC</tradeName>
    <deviceName>Vitamin D xPOC</deviceName>
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    <deviceName>Stop Solution</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
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    <reference>00-5007-01</reference>
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    <deviceName>Washing Solution 4x conc.</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
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    <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>
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    <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>
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    <deviceName>ALEX Air</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <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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    <deviceName>ALEX³ Allergy Xplorer</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-2001-01</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:41:13.882Z</lastUpdated>
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    <deviceName>ALEX² Allergy Xplorer</deviceName>
    <manufacturerName>MacroArray Diagnostics</manufacturerName>
    <manufacturerSrn>AT-MF-000030541</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <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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    <udiDi>09120095900052</udiDi>
    <basicUdiDi>912009590FEM012L</basicUdiDi>
    <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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    <udiDi>08905459006721</udiDi>
    <basicUdiDi>8905459OVULHRDTSFA5</basicUdiDi>
    <tradeName>OvuFind</tradeName>
    <deviceName>OvuFind™ Ovulation Rapid Test</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160304</emdnCode>
    <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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    <udiDi>08806133048498</udiDi>
    <basicUdiDi>880613306069DH</basicUdiDi>
    <tradeName>Boditech PSA Control</tradeName>
    <deviceName>Boditech PSA Control</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <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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    <udiDi>08806133046975</udiDi>
    <basicUdiDi>880613300509CE</basicUdiDi>
    <tradeName>AFIAS Total βhCG</tradeName>
    <deviceName>AFIAS Total βhCG</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-3</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:53.878Z</lastUpdated>
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    <udiDi>08806133045473</udiDi>
    <basicUdiDi>880613300117BR</basicUdiDi>
    <tradeName>ichroma™ Total IgE</tradeName>
    <deviceName>ichroma™ Total IgE</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>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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    <udiDi>08806133045374</udiDi>
    <basicUdiDi>880613300516CB</basicUdiDi>
    <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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    <udiDi>08806133041314</udiDi>
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    <tradeName>AFIAS Vitamin D Neo</tradeName>
    <deviceName>AFIAS Vitamin D Neo</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-108</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:41.418Z</lastUpdated>
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    <tradeName>AFIAS Cortisol</tradeName>
    <deviceName>AFIAS Cortisol</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>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:37.073Z</lastUpdated>
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    <tradeName>AFIAS Testosterone</tradeName>
    <deviceName>AFIAS Testosterone</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-29</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:34.937Z</lastUpdated>
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    <tradeName>Laboquick</tradeName>
    <deviceName>Laboquick Ovulation Test</deviceName>
    <manufacturerName>Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032257</manufacturerSrn>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBOV.01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:41:42.682Z</lastUpdated>
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    <tradeName>Laboquick</tradeName>
    <deviceName>Laboquick Pregnancy Cassette Test</deviceName>
    <manufacturerName>Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Ltd. Sti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032257</manufacturerSrn>
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    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LBHG.01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T20:41:38.686Z</lastUpdated>
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