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<eudamedExport entity="devices">
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    <tradeName>CancerCheck® PSA</tradeName>
    <deviceName>PSA Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K32-PSA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:07:17.142Z</lastUpdated>
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    <udiDi>06971100210917</udiDi>
    <basicUdiDi>B-06971100210917</basicUdiDi>
    <tradeName>SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>SARS-CoV-2 Antigen Rapid Test(Colloidal Gold)</deviceName>
    <manufacturerName>Xiamen Wiz Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029590</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51332801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:08:18.819Z</lastUpdated>
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    <udiDi>05060274503046</udiDi>
    <basicUdiDi>B-05060274503046</basicUdiDi>
    <tradeName>BPR Medical</tradeName>
    <deviceName>Service Exchange - Analgesic Demand Valve - 3m Hose -Nordica</deviceName>
    <manufacturerName>BPR Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000003347</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9099</emdnCode>
    <emdnDescription>RESPIRATORY AND ANAESTHESIA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>828-3003S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:24:05.504Z</lastUpdated>
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    <udiDi>00860396001988</udiDi>
    <basicUdiDi>B-00860396001988</basicUdiDi>
    <tradeName>00860396001988</tradeName>
    <deviceName>NIO Glioma Reveal</deviceName>
    <manufacturerName>Invenio Imaging Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000047250</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0202050382</emdnCode>
    <emdnDescription>LABORATORY INSTRUMENTS FOR MICROSCOPIC INVESTIGATIONS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRT 04-0032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:50.902Z</lastUpdated>
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  <row>
    <udiDi>00860006973537</udiDi>
    <basicUdiDi>B-00860006973537</basicUdiDi>
    <tradeName>AAV5 NAb Test</tradeName>
    <deviceName>AAV5 Neutralizing Antibody (NAb) Test</deviceName>
    <manufacturerName>Precision for Medicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007346</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC201301EU</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:06.824Z</lastUpdated>
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  <row>
    <udiDi>00859462006415</udiDi>
    <basicUdiDi>B-00859462006415</basicUdiDi>
    <tradeName>23andMe Personal Genome Service</tradeName>
    <deviceName>23andMe PGS Coregen Software</deviceName>
    <manufacturerName>23andMe Genomics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000022267</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Product Segment = Consumer</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:57.122Z</lastUpdated>
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  <row>
    <udiDi>00859462006408</udiDi>
    <basicUdiDi>B-00859462006408</basicUdiDi>
    <tradeName>23andMe Personal Genome Service</tradeName>
    <deviceName>23andMe PGS Coregen Software</deviceName>
    <manufacturerName>23andMe Genomics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000022267</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Product Segment = Consumer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:55.522Z</lastUpdated>
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    <udiDi>00859462006392</udiDi>
    <basicUdiDi>B-00859462006392</basicUdiDi>
    <tradeName>23andMe Personal Genome Service</tradeName>
    <deviceName>23andMe PGS Coregen Software</deviceName>
    <manufacturerName>23andMe Genomics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000022267</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Product Segment = Consumer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:53.122Z</lastUpdated>
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  <row>
    <udiDi>00859462006385</udiDi>
    <basicUdiDi>B-00859462006385</basicUdiDi>
    <tradeName>23andMe Personal Genome Service</tradeName>
    <deviceName>23andMe PGS Coregen Software</deviceName>
    <manufacturerName>23andMe Genomics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000022267</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Product Segment = Consumer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:51.521Z</lastUpdated>
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  <row>
    <udiDi>00859462006378</udiDi>
    <basicUdiDi>B-00859462006378</basicUdiDi>
    <tradeName>23andMe Personal Genome Service</tradeName>
    <deviceName>23andMe PGS Coregen Software</deviceName>
    <manufacturerName>23andMe Genomics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000022267</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Product Segment = Consumer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:50.744Z</lastUpdated>
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    <udiDi>00859462006262</udiDi>
    <basicUdiDi>B-00859462006262</basicUdiDi>
    <tradeName>23andMe Personal Genome Service</tradeName>
    <deviceName>23andMe PGS Coregen Software</deviceName>
    <manufacturerName>23andMe Genomics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000022267</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Product Segment = Consumer</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:49.120Z</lastUpdated>
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  <row>
    <udiDi>00850082432226</udiDi>
    <basicUdiDi>B-00850082432226</basicUdiDi>
    <tradeName>25 OH Quantitative Rapid Vitamin D Test</tradeName>
    <deviceName>25 OH Quantitative Rapid 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>GDB7120-25T</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:58.839Z</lastUpdated>
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  <row>
    <udiDi>00850082432219</udiDi>
    <basicUdiDi>B-00850082432219</basicUdiDi>
    <tradeName>OnSight™ - Vitamin B12 Quantitative Test</tradeName>
    <deviceName>OnSight™ - Vitamin B12 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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>665-25-DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:58.037Z</lastUpdated>
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  <row>
    <udiDi>00850082432202</udiDi>
    <basicUdiDi>B-00850082432202</basicUdiDi>
    <tradeName>BodyCheck Vitamin B12</tradeName>
    <deviceName>BodyCheck Vitamin B12</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-C52-VB12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:54.022Z</lastUpdated>
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  <row>
    <udiDi>00850082432196</udiDi>
    <basicUdiDi>B-00850082432196</basicUdiDi>
    <tradeName>TestNOW® - Vitamin B12 Quantitative Test</tradeName>
    <deviceName>TestNOW® - Vitamin B12 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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1177Q-25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:53.224Z</lastUpdated>
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    <udiDi>00850082432189</udiDi>
    <basicUdiDi>B-00850082432189</basicUdiDi>
    <tradeName>Vitamin D Control – OnSight™ Vitamin D Quantitative Test</tradeName>
    <deviceName>Vitamin D Control – 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>711-VDC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:52.430Z</lastUpdated>
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    <udiDi>00850082432172</udiDi>
    <basicUdiDi>B-00850082432172</basicUdiDi>
    <tradeName>Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>Vitamin D Control – botiss CARE 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1156-VDC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:51.625Z</lastUpdated>
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    <udiDi>00850082432165</udiDi>
    <basicUdiDi>B-00850082432165</basicUdiDi>
    <tradeName>Vitamin D Control – CrinoCheck® Vitamin D</tradeName>
    <deviceName>Vitamin D Control – 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-VITD-K</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:47.629Z</lastUpdated>
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    <udiDi>00850082432158</udiDi>
    <basicUdiDi>B-00850082432158</basicUdiDi>
    <tradeName>Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test</tradeName>
    <deviceName>Vitamin D Control – 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1155-VDC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:46.838Z</lastUpdated>
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    <udiDi>00850082432141</udiDi>
    <basicUdiDi>B-00850082432141</basicUdiDi>
    <tradeName>OnSight™ Cortisol Quantitative Test</tradeName>
    <deviceName>OnSight™ 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>655-25-DB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:46.032Z</lastUpdated>
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