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    <tradeName>A-Gene Metabolic kit</tradeName>
    <deviceName>A-Gene Metabolic kit</deviceName>
    <manufacturerName>iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ref.007</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:33:51.563Z</lastUpdated>
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    <udiDi>D-0520042350018669</udiDi>
    <basicUdiDi>B-0520042350018669</basicUdiDi>
    <tradeName>Healthy Heart kit</tradeName>
    <deviceName>Healthy Heart kit</deviceName>
    <manufacturerName>iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>04053228029083</udiDi>
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    <tradeName>04053228029083</tradeName>
    <deviceName>QIAsure Methylation Test</deviceName>
    <manufacturerName>Self-screen B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000040204</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:23:16.110Z</lastUpdated>
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    <udiDi>04050598014916</udiDi>
    <basicUdiDi>B-04050598014916</basicUdiDi>
    <tradeName>MutaREAL® UGT1A1 Real-Time-PCR-Kit</tradeName>
    <deviceName>MutaREAL® UGT1A1 Real-Time-PCR-Kit</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF091896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:44.844Z</lastUpdated>
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    <udiDi>04050598014909</udiDi>
    <basicUdiDi>B-04050598014909</basicUdiDi>
    <tradeName>MutaREAL® UGT1A1 Real-Time-PCR-Kit</tradeName>
    <deviceName>MutaREAL® UGT1A1 Real-Time-PCR-Kit</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF091832</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:50:29.481Z</lastUpdated>
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  <row>
    <udiDi>04050598010789</udiDi>
    <basicUdiDi>B-04050598010789</basicUdiDi>
    <tradeName>MutaPLATE® COMT, PCR</tradeName>
    <deviceName>MutaPLATE® COMT, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF191596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:49:14.187Z</lastUpdated>
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  <row>
    <udiDi>04050598008434</udiDi>
    <basicUdiDi>B-04050598008434</basicUdiDi>
    <tradeName>MutaREAL DPD-2, PCR</tradeName>
    <deviceName>MutaREAL DPD-2, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF292096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:14.786Z</lastUpdated>
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  <row>
    <udiDi>04050598008427</udiDi>
    <basicUdiDi>B-04050598008427</basicUdiDi>
    <tradeName>MutaREAL DPD-2, PCR</tradeName>
    <deviceName>MutaREAL DPD-2, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF292032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:47:13.997Z</lastUpdated>
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  <row>
    <udiDi>04050598003569</udiDi>
    <basicUdiDi>B-04050598003569</basicUdiDi>
    <tradeName>MutaREAL® UGT1A1</tradeName>
    <deviceName>MutaREAL® UGT1A1</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF291896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:43:07.277Z</lastUpdated>
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  <row>
    <udiDi>04050598002937</udiDi>
    <basicUdiDi>B-04050598002937</basicUdiDi>
    <tradeName>MutaREAL® UGT1A1, PCR</tradeName>
    <deviceName>MutaREAL® UGT1A1, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF291832</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:19.991Z</lastUpdated>
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    <udiDi>04049095250019</udiDi>
    <basicUdiDi>B-04049095250019</basicUdiDi>
    <tradeName>04049095250019</tradeName>
    <deviceName>RIDA®PRECISION ABCB1</deviceName>
    <manufacturerName>R-Biopharm AG</manufacturerName>
    <manufacturerSrn>DE-MF-000007993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y5500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:06:37.925Z</lastUpdated>
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  <row>
    <udiDi>D-01001DP</udiDi>
    <basicUdiDi>B-01001DP</basicUdiDi>
    <tradeName>GA-map® Dysbiosis Test Lx v2</tradeName>
    <deviceName>GA-map® Dysbiosis Test Lx v2</deviceName>
    <manufacturerName>Genetic Analysis AS</manufacturerName>
    <manufacturerSrn>NO-MF-000023768</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:41.100Z</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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    <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>
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    <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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    <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>
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    <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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    <udiDi>00850052003630</udiDi>
    <basicUdiDi>B-00850052003630</basicUdiDi>
    <tradeName>T Cell Receptor Gamma Gene Rearrangement</tradeName>
    <deviceName>T Cell Receptor Gamma Gene Rearrangement Assay 2.0 Megakit</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-207-0111</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:20.918Z</lastUpdated>
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    <udiDi>00850052003623</udiDi>
    <basicUdiDi>B-00850052003623</basicUdiDi>
    <tradeName>T Cell Receptor Gamma Gene Rearrangement</tradeName>
    <deviceName>T Cell Receptor Gamma Gene Rearrangement Assay 2.0</deviceName>
    <manufacturerName>Invivoscribe, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011736</manufacturerSrn>
    <authorisedRepresentativeName>IN VIVOSCRIBE TECHNOLOGIES</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000003774</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9-207-0101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:16.939Z</lastUpdated>
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