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    <tradeName>D-5391540380FP-007SY6C</tradeName>
    <deviceName>Kappa Chain Probe Detection Kit</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:38:12.830Z</lastUpdated>
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    <udiDi>D-5391540380FP-006SW63</udiDi>
    <basicUdiDi>B-5391540380FP-006SW63</basicUdiDi>
    <tradeName>D-5391540380FP-006SW63</tradeName>
    <deviceName>ROS1 (6q22) gene break apart rearrangement detection probe</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>D-5391540380FP-005SU5S</udiDi>
    <basicUdiDi>B-5391540380FP-005SU5S</basicUdiDi>
    <tradeName>D-5391540380FP-005SU5S</tradeName>
    <deviceName>PML/RARA gene fusion probe</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <basicUdiDi>B-5391540380FP-004SS5H</basicUdiDi>
    <tradeName>D-5391540380FP-004SS5H</tradeName>
    <deviceName>AML1/ETO gene fusion detection probe</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:38:09.576Z</lastUpdated>
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    <udiDi>D-5391540380FP-003SQ58</udiDi>
    <basicUdiDi>B-5391540380FP-003SQ58</basicUdiDi>
    <tradeName>D-5391540380FP-003SQ58</tradeName>
    <deviceName>BCR/ABL gene fusion detection probe</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:38:05.863Z</lastUpdated>
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    <udiDi>D-5391540380FP-002SN4V</udiDi>
    <basicUdiDi>B-5391540380FP-002SN4V</basicUdiDi>
    <tradeName>D-5391540380FP-002SN4V</tradeName>
    <deviceName>Human ALK gene fusion detection probe</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:38:05.737Z</lastUpdated>
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    <udiDi>04250380305097</udiDi>
    <basicUdiDi>4250380P144QW</basicUdiDi>
    <tradeName>04250380305097</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZytoVision GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000024390</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z-2096-200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:57:54.977Z</lastUpdated>
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    <udiDi>0069718CL0123G</udiDi>
    <basicUdiDi>069718082CL0045L</basicUdiDi>
    <tradeName>0069718CL0123G</tradeName>
    <deviceName>In Situ Hybridization Staining Solution</deviceName>
    <manufacturerName>OACP IE LTD</manufacturerName>
    <manufacturerSrn>IE-MF-000003506</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:13:36.773Z</lastUpdated>
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    <udiDi>06974604726540</udiDi>
    <basicUdiDi>B-06974604726540</basicUdiDi>
    <tradeName>06974604726540</tradeName>
    <deviceName>ROS1 Dual Color Break Apart Probe (fluorescence in situ hybridization )</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVDD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:03:26.140Z</lastUpdated>
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    <udiDi>06974604726342</udiDi>
    <basicUdiDi>B-06974604726342</basicUdiDi>
    <tradeName>06974604726342</tradeName>
    <deviceName>IGH  Dual Color Break Apart Probe (fluorescence in situ hybridization )</deviceName>
    <manufacturerName>Wuhan YZY Medical Science and Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036323</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVDD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:02:54.128Z</lastUpdated>
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    <udiDi>06927210914092</udiDi>
    <basicUdiDi>B-06927210914092</basicUdiDi>
    <tradeName>ISH Lambda Probe</tradeName>
    <deviceName>ISH Lambda Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0580</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:33.734Z</lastUpdated>
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    <udiDi>06927210914085</udiDi>
    <basicUdiDi>B-06927210914085</basicUdiDi>
    <tradeName>ISH Lambda Probe</tradeName>
    <deviceName>ISH Lambda Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0580</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:32.944Z</lastUpdated>
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    <udiDi>06927210914078</udiDi>
    <basicUdiDi>B-06927210914078</basicUdiDi>
    <tradeName>ISH Lambda Probe</tradeName>
    <deviceName>ISH Lambda Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0580</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:32.245Z</lastUpdated>
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    <udiDi>06927210914061</udiDi>
    <basicUdiDi>B-06927210914061</basicUdiDi>
    <tradeName>ISH Lambda Probe</tradeName>
    <deviceName>ISH Lambda Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0580</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:27.332Z</lastUpdated>
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    <udiDi>06927210914054</udiDi>
    <basicUdiDi>B-06927210914054</basicUdiDi>
    <tradeName>ISH Kappa Probe</tradeName>
    <deviceName>ISH Kappa Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0579</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:26.552Z</lastUpdated>
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    <udiDi>06927210914047</udiDi>
    <basicUdiDi>B-06927210914047</basicUdiDi>
    <tradeName>ISH Kappa Probe</tradeName>
    <deviceName>ISH Kappa Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0579</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:25.739Z</lastUpdated>
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    <udiDi>06927210914030</udiDi>
    <basicUdiDi>B-06927210914030</basicUdiDi>
    <tradeName>ISH Kappa Probe</tradeName>
    <deviceName>ISH Kappa Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0579</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:24.937Z</lastUpdated>
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    <basicUdiDi>B-06927210914023</basicUdiDi>
    <tradeName>ISH Kappa Probe</tradeName>
    <deviceName>ISH Kappa Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0579</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:20.954Z</lastUpdated>
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    <basicUdiDi>B-06927210913972</basicUdiDi>
    <tradeName>ISH EBER Probe</tradeName>
    <deviceName>ISH EBER Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0577</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:14.137Z</lastUpdated>
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    <udiDi>06927210913965</udiDi>
    <basicUdiDi>B-06927210913965</basicUdiDi>
    <tradeName>ISH EBER Probe</tradeName>
    <deviceName>ISH EBER Probe</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMRD0577</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:16:12.224Z</lastUpdated>
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