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    <basicUdiDi>B-00850082432134</basicUdiDi>
    <tradeName>CrinoCheck® Cortisol</tradeName>
    <deviceName>CrinoCheck® Cortisol</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-C42-CORT</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:45.219Z</lastUpdated>
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    <udiDi>00850082432127</udiDi>
    <basicUdiDi>B-00850082432127</basicUdiDi>
    <tradeName>TestNOW® Cortisol Quantitative Test</tradeName>
    <deviceName>TestNOW® Cortisol Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1175Q-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:29.949Z</lastUpdated>
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    <udiDi>00850082432110</udiDi>
    <basicUdiDi>B-00850082432110</basicUdiDi>
    <tradeName>OnSight™ Testosterone Quantitative Test</tradeName>
    <deviceName>OnSight™ Testosterone Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650-25-DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:29.151Z</lastUpdated>
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    <udiDi>00850082432103</udiDi>
    <basicUdiDi>B-00850082432103</basicUdiDi>
    <tradeName>CrinoCheck® Testosterone</tradeName>
    <deviceName>CrinoCheck® Testosterone</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-C42-TESTO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:25.142Z</lastUpdated>
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  <row>
    <udiDi>00850082432097</udiDi>
    <basicUdiDi>B-00850082432097</basicUdiDi>
    <tradeName>TestNOW® Testosterone Quantitative Test</tradeName>
    <deviceName>TestNOW® Testosterone Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1173Q-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:24.350Z</lastUpdated>
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    <udiDi>00850082432080</udiDi>
    <basicUdiDi>B-00850082432080</basicUdiDi>
    <tradeName>OnSight™ Ferritin Quantitative Test</tradeName>
    <deviceName>OnSight™ Ferritin Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>670-25-DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:23.546Z</lastUpdated>
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  <row>
    <udiDi>00850082432073</udiDi>
    <basicUdiDi>B-00850082432073</basicUdiDi>
    <tradeName>BodyCheck Ferritin</tradeName>
    <deviceName>BodyCheck Ferritin</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-C52-FERR</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:22.740Z</lastUpdated>
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    <udiDi>00850082432066</udiDi>
    <basicUdiDi>B-00850082432066</basicUdiDi>
    <tradeName>VHC Vitamin D Test</tradeName>
    <deviceName>VHC Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000J-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:18.756Z</lastUpdated>
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  <row>
    <udiDi>00850082432059</udiDi>
    <basicUdiDi>B-00850082432059</basicUdiDi>
    <tradeName>BIOSYNEX Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>BIOSYNEX Rapi-D™ Quantitative Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1157Q-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:17.937Z</lastUpdated>
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  <row>
    <udiDi>00850082432042</udiDi>
    <basicUdiDi>B-00850082432042</basicUdiDi>
    <tradeName>botissCARE Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>botissCARE Rapi-D™ Quantitative Vitamin D Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1156Q-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:17.133Z</lastUpdated>
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  <row>
    <udiDi>00850082432035</udiDi>
    <basicUdiDi>B-00850082432035</basicUdiDi>
    <tradeName>CrinoCheck® Vitamin D</tradeName>
    <deviceName>CrinoCheck® Vitamin D</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-C42-VITD25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:16.349Z</lastUpdated>
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  <row>
    <udiDi>00850082432028</udiDi>
    <basicUdiDi>B-00850082432028</basicUdiDi>
    <tradeName>OnSight™- Vitamin D Quantitative Test</tradeName>
    <deviceName>OnSight™- Vitamin D Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>711-25-DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:12.325Z</lastUpdated>
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  <row>
    <udiDi>00850082432004</udiDi>
    <basicUdiDi>B-00850082432004</basicUdiDi>
    <tradeName>TestNOW® Ferritin Quantitative Test</tradeName>
    <deviceName>TestNOW® Ferritin Quantitative Test</deviceName>
    <manufacturerName>Affimedix, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000053178</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1179Q-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:11.538Z</lastUpdated>
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    <udiDi>+B091111010O</udiDi>
    <basicUdiDi>++B091PrismsTY</basicUdiDi>
    <tradeName>Single Prism - 1 Diopter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.237Z</lastUpdated>
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    <udiDi>+B09111101100O</udiDi>
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    <tradeName>Single Prism - 10 Diopter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.213Z</lastUpdated>
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    <udiDi>+B09111101120Q</udiDi>
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    <tradeName>Single Prism - 12 Diopter</tradeName>
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    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.192Z</lastUpdated>
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    <udiDi>+B09111101140S</udiDi>
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    <tradeName>Single Prism - 14 Diopter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-14</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.166Z</lastUpdated>
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    <udiDi>+B09111101150T</udiDi>
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    <tradeName>Single Prism - 15 Diopter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.140Z</lastUpdated>
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    <tradeName>Single Prism - 16 Diopter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.116Z</lastUpdated>
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    <udiDi>+B09111101180W</udiDi>
    <basicUdiDi>++B091PrismsTY</basicUdiDi>
    <tradeName>Single Prism - 18 Diopter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gulden Ophthalmics</manufacturerName>
    <manufacturerSrn>US-MF-000008608</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERAPEUTIC AND SURGICAL OPHTHOLMOLOGICAL TREATMENTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11101-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:28.094Z</lastUpdated>
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