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    <tradeName>CanAg Glypican-3 EIA</tradeName>
    <deviceName>CanAg Glypican-3 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503-10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:24:22.293Z</lastUpdated>
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    <tradeName>AMH Control</tradeName>
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    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152099</emdnCode>
    <emdnDescription>CONTROLS- IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660-20</reference>
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    <lastUpdated>2026-07-31T19:24:21.489Z</lastUpdated>
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    <tradeName>HE4 EIA</tradeName>
    <deviceName>HE4 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>404-10</reference>
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    <lastUpdated>2026-07-31T19:24:17.483Z</lastUpdated>
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    <tradeName>CanAg Free PSA EIA</tradeName>
    <deviceName>CanAg Free PSA EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>350-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:15:44.862Z</lastUpdated>
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    <udiDi>17350066140173</udiDi>
    <basicUdiDi>73500661401799</basicUdiDi>
    <tradeName>CanAg PSA EIA</tradeName>
    <deviceName>CanAg PSA EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:15:44.072Z</lastUpdated>
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    <udiDi>17350066140135</udiDi>
    <basicUdiDi>7350066140138Z</basicUdiDi>
    <tradeName>CYFRA 21-1 EIA</tradeName>
    <deviceName>CYFRA 21-1 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:15:43.263Z</lastUpdated>
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    <udiDi>06979890910581</udiDi>
    <basicUdiDi>69798909110042CT</basicUdiDi>
    <tradeName>Multi-Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-1x4a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:59.037Z</lastUpdated>
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    <tradeName>Multi-Drug 5 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-154a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:56.640Z</lastUpdated>
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    <udiDi>06979890910574</udiDi>
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    <tradeName>Multi-Drug 4 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-144a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:53.608Z</lastUpdated>
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    <udiDi>06979890910550</udiDi>
    <basicUdiDi>69798909110061CX</basicUdiDi>
    <tradeName>Multi-Drug 6 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-164a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:39.777Z</lastUpdated>
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    <udiDi>06979890910543</udiDi>
    <basicUdiDi>69798909110062CZ</basicUdiDi>
    <tradeName>Multi-Drug 7 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-174a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:37.615Z</lastUpdated>
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    <udiDi>06979890910536</udiDi>
    <basicUdiDi>69798909110063D3</basicUdiDi>
    <tradeName>Multi-Drug 8 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-184a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:37.611Z</lastUpdated>
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    <udiDi>06979890910529</udiDi>
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    <tradeName>Multi-Drug 9 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-194a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:35.077Z</lastUpdated>
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    <udiDi>06979890910512</udiDi>
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    <tradeName>Multi-Drug 10 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Multi-Drug 10 Drugs Test Panel(Urine)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:35.012Z</lastUpdated>
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    <udiDi>06979890910499</udiDi>
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    <tradeName>Multi-Drug 11 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
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    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-1114a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:29.376Z</lastUpdated>
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    <tradeName>Multi-Drug 12 Drugs Test Panel(Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medotex Biotech (HangZhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051631</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA-1124a-001-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:53:28.558Z</lastUpdated>
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    <tradeName>Buffer</tradeName>
    <deviceName>Buffer</deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029003</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6620-PA00002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:52:37.625Z</lastUpdated>
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    <basicUdiDi>697806677PR007QU</basicUdiDi>
    <tradeName>Serum Amyloid A (SAA) Calibrator</tradeName>
    <deviceName>Serum Amyloid A (SAA) Calibrator</deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7090-PA00002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:52:37.610Z</lastUpdated>
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    <udiDi>06976667950030</udiDi>
    <basicUdiDi>697666795DOAZ8</basicUdiDi>
    <tradeName>BIO-INSTANT</tradeName>
    <deviceName>Multi-Drug Rapid Test 14 Drugs in 1 Combo Panel (OPI2000/MDMA500/MOP300/OXY100/MTD300/PCP25/COC300/AMP1000/MET1000/BAR300/EDDP100/THC50/BZO300/BUP10)</deviceName>
    <manufacturerName>Hangzhou ELIT Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043511</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDOA-124~1144</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:50:55.687Z</lastUpdated>
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    <udiDi>06936700408508</udiDi>
    <basicUdiDi>697541776017MX</basicUdiDi>
    <tradeName>Glycosylated Hemoglobin Hemolytic Agent</tradeName>
    <deviceName>Glycosylated Hemoglobin Hemolytic Agent</deviceName>
    <manufacturerName>Hotgen (Langfang) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018899</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGOTHER01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:39:50.132Z</lastUpdated>
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