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    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-06-22T14:06:19.247Z</lastUpdated>
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    <manufacturerName>DNA Genotek Inc.</manufacturerName>
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    <tradeName>ORAgene ONE</tradeName>
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    <manufacturerName>DNA Genotek Inc.</manufacturerName>
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    <tradeName>ORAgene ONE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>0627595E0500GF</basicUdiDi>
    <tradeName>ORAgene DNA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>OG-610</reference>
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    <lastUpdated>2026-06-22T14:06:19.113Z</lastUpdated>
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    <udiDi>00627595000798</udiDi>
    <basicUdiDi>0627595F0600GX</basicUdiDi>
    <tradeName>OMNIgene ORAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA Genotek Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000003486</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OME-505.005</reference>
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    <lastUpdated>2026-06-22T14:06:18.989Z</lastUpdated>
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    <udiDi>00850027600123</udiDi>
    <basicUdiDi>0850027600R1160FL</basicUdiDi>
    <tradeName>DNA/RNA Shield SafeCollect Swab Collection Kit - 1ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000006724</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1160-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:43.141Z</lastUpdated>
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    <udiDi>00850027600130</udiDi>
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    <tradeName>DNA/RNA Shield SafeCollect Swab Collection Kit - 2ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1161-E</reference>
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    <lastUpdated>2026-06-21T22:45:43.117Z</lastUpdated>
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    <basicUdiDi>0850027600R1160FL</basicUdiDi>
    <tradeName>DNA/RNA Shield SafeCollect Swab Collection Kit - 1ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000006724</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N1112-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:42.569Z</lastUpdated>
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    <udiDi>04251620700153</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Freies Testosteron Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:52.942Z</lastUpdated>
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    <udiDi>04251620700177</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Melatonin Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:52.918Z</lastUpdated>
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    <udiDi>04251620700214</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Freies Östrogen Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:52.896Z</lastUpdated>
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    <udiDi>04251620701600</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Cortisol Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010135</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:52.754Z</lastUpdated>
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    <udiDi>04251620701617</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Freies Testosteron Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010136</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:52.733Z</lastUpdated>
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    <udiDi>04251620701631</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Melatonin Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010138</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:52.690Z</lastUpdated>
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    <udiDi>04251620701679</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Freies Östrogen Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010142</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:52.652Z</lastUpdated>
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    <udiDi>04251620706247</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Coronavirus PCR Speichel Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>99010424</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:34.032Z</lastUpdated>
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    <udiDi>04251620711128</udiDi>
    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Cortisol Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010022-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:31.706Z</lastUpdated>
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    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Freies Testosteron Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010023-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:31.635Z</lastUpdated>
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    <basicUdiDi>42516207005JX</basicUdiDi>
    <tradeName>cerascreen® Cortisol Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cerascreen GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000017602</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99010618</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:14:31.491Z</lastUpdated>
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