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<eudamedExport entity="devices">
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    <udiDi>15065026245295</udiDi>
    <basicUdiDi>B-15065026245295</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>CEA Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20042</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:57.313Z</lastUpdated>
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  <row>
    <udiDi>D-1081-1LS</udiDi>
    <basicUdiDi>B-1081-1LS</basicUdiDi>
    <tradeName>Fortel Prostate (PSA) Screening Test</tradeName>
    <deviceName>Fortel Prostate (PSA) Screening Test</deviceName>
    <manufacturerName>BIOEUROPE GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000039230</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1081-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:18:12.006Z</lastUpdated>
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    <udiDi>08697962616299</udiDi>
    <basicUdiDi>B-08697962616299</basicUdiDi>
    <tradeName>SOFTEC Creatine Kinase-MB Rapid Test Kit</tradeName>
    <deviceName>CK-MB Rapid Test Kit</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFCKMB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:51.984Z</lastUpdated>
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    <udiDi>08429577001616</udiDi>
    <basicUdiDi>B-08429577001616</basicUdiDi>
    <tradeName>Simple PSA / Stick PSA</tradeName>
    <deviceName>Simple PSA / Stick PSA</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.444.030.00.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:27:56.773Z</lastUpdated>
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  <row>
    <udiDi>06936983190718</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402H-02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:45.074Z</lastUpdated>
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  <row>
    <udiDi>06936983190725</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402H-01B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:45.049Z</lastUpdated>
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  <row>
    <udiDi>06936983190732</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402H-02B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:45.031Z</lastUpdated>
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  <row>
    <udiDi>06936983190749</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HB-01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:45.006Z</lastUpdated>
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  <row>
    <udiDi>06936983190756</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HB-02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:44.984Z</lastUpdated>
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  <row>
    <udiDi>06936983190763</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HB-01B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:44.961Z</lastUpdated>
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  <row>
    <udiDi>06936983190770</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HB-02B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:44.940Z</lastUpdated>
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  <row>
    <udiDi>06936983190787</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HJ-01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:44.921Z</lastUpdated>
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  <row>
    <udiDi>06936983190794</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HJ-02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:44.898Z</lastUpdated>
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  <row>
    <udiDi>06936983190800</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HJ-01B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:44.871Z</lastUpdated>
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  <row>
    <udiDi>06936983190817</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HJ-02B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:47:44.839Z</lastUpdated>
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    <udiDi>07640164860084</udiDi>
    <basicUdiDi>B-07640164860084</basicUdiDi>
    <tradeName>Newfoundland</tradeName>
    <deviceName>Newfoundland Prostate Health test</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880080-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:04:07.502Z</lastUpdated>
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    <udiDi>06976374752132</udiDi>
    <basicUdiDi>B-06976374752132</basicUdiDi>
    <tradeName>Free Prostate Specific Antigen (f-PSA) Detection Kit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Free Prostate Specific Antigen (f-PSA) Detection Kit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR080-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:14.923Z</lastUpdated>
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    <udiDi>06976374752125</udiDi>
    <basicUdiDi>B-06976374752125</basicUdiDi>
    <tradeName>Total Prostate Specific Antigen (t-PSA) Detection Kit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Total Prostate Specific Antigen (t-PSA) Detection Kit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR079-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:14.121Z</lastUpdated>
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    <udiDi>06975424225916</udiDi>
    <basicUdiDi>B-06975424225916</basicUdiDi>
    <tradeName>PSA Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>PSA Assay Kit  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248601C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:44:20.630Z</lastUpdated>
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    <udiDi>06975424223516</udiDi>
    <basicUdiDi>B-06975424223516</basicUdiDi>
    <tradeName>PSA Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>PSA Assay Kit  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248601</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:26.446Z</lastUpdated>
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