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    <tradeName>ProGRP Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0505102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:57:05.090Z</lastUpdated>
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    <udiDi>06933260206827</udiDi>
    <basicUdiDi>B-06933260206827</basicUdiDi>
    <tradeName>ProGRP Rapid Quantitative Test (Chemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0505101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:57:03.889Z</lastUpdated>
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    <udiDi>00615233001009</udiDi>
    <basicUdiDi>06152338223J4</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8280-M250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:33:45.746Z</lastUpdated>
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    <udiDi>00615233010407</udiDi>
    <basicUdiDi>06152338274JM</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8344-M250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:33:45.714Z</lastUpdated>
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    <udiDi>00615233010599</udiDi>
    <basicUdiDi>06152338271JF</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8388-C010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:33:45.670Z</lastUpdated>
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    <udiDi>00615233010681</udiDi>
    <basicUdiDi>06152338275JP</basicUdiDi>
    <tradeName>Tissue-Tek Genie®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8276-M250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:33:45.607Z</lastUpdated>
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    <udiDi>00615233011329</udiDi>
    <basicUdiDi>06152338304J5</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8337-C010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:33:45.513Z</lastUpdated>
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    <udiDi>00615233014009</udiDi>
    <basicUdiDi>06152338310HY</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-TRPS1 Rabbit Polyclonal Antibody [ZR382]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8359-C010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:33:45.381Z</lastUpdated>
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    <udiDi>00615233014566</udiDi>
    <basicUdiDi>06152338309JF</basicUdiDi>
    <tradeName>Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sakura Finetek USA, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022208</manufacturerSrn>
    <authorisedRepresentativeName>Sakura Finetek Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000007853</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039099</emdnCode>
    <emdnDescription>TUMOUR MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8379-M250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:33:45.323Z</lastUpdated>
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    <udiDi>00630414177335</udiDi>
    <basicUdiDi>0405686901798WQ</basicUdiDi>
    <tradeName>ADVIA Centaur® AFP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309980</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:39.879Z</lastUpdated>
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    <udiDi>00630414597706</udiDi>
    <basicUdiDi>0405686901798WQ</basicUdiDi>
    <tradeName>Atellica IM Alpha Fetoprotein (AFP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995441</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:38.467Z</lastUpdated>
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    <udiDi>00630414597713</udiDi>
    <basicUdiDi>0405686901798WQ</basicUdiDi>
    <tradeName>Atellica IM Alpha Fetoprotein (AFP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995442</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:35:38.434Z</lastUpdated>
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    <udiDi>04987026117423</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Latex Reagent (for OC-SENSOR Micro)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH33</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.323Z</lastUpdated>
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    <udiDi>04987026165837</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Latex Reagent (for OC-SENSOR DIANA, PLEDIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.200Z</lastUpdated>
  </row>
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    <udiDi>04987026165844</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Buffer (for OC-SENSOR DIANA, PLEDIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.181Z</lastUpdated>
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    <udiDi>04987026182308</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-SENSOR FIT Latex Reagent (for OC-SENSOR io)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.166Z</lastUpdated>
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    <udiDi>04987026182322</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Calibrator (for OC-SENSOR DIANA, Micro)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH51</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.149Z</lastUpdated>
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    <udiDi>04987026182339</udiDi>
    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Calibrator (for OC-SENSOR PLEDIA, io)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH52</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.133Z</lastUpdated>
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    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Control LV1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH53</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.113Z</lastUpdated>
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    <basicUdiDi>4987026TD-OCHBYG</basicUdiDi>
    <tradeName>OC-FIT Control LV2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102039013</emdnCode>
    <emdnDescription>TUMOUR MARKER CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH54</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.094Z</lastUpdated>
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