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    <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>
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    <reference>C-3001-400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:20:53.818Z</lastUpdated>
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    <udiDi>D-200460LP</udiDi>
    <basicUdiDi>B-200460LP</basicUdiDi>
    <tradeName>RNAscope™ ISH Probe UBC (Positive Control)</tradeName>
    <deviceName>RNAscope™ ISH Probe UBC (Positive Control)</deviceName>
    <manufacturerName>Advanced Cell Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000047789</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W01030703</emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
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    <lastUpdated>2026-07-30T15:08:24.074Z</lastUpdated>
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    <udiDi>D-200450LL</udiDi>
    <basicUdiDi>B-200450LL</basicUdiDi>
    <tradeName>RNAscope™ ISH Probe High Risk HPV</tradeName>
    <deviceName>RNAscope™ ISH Probe High Risk HPV</deviceName>
    <manufacturerName>Advanced Cell Diagnostics</manufacturerName>
    <manufacturerSrn>US-MF-000047789</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>D-539154038FP-315-23DGG</udiDi>
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    <tradeName>D-539154038FP-315-23DGG</tradeName>
    <deviceName>RUNX1 (21q22) gene probe reagent (RUNX1/21q22.3)</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-315-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:56.112Z</lastUpdated>
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    <udiDi>D-539154038FP-232-333EV</udiDi>
    <basicUdiDi>B-539154038FP-232-333EV</basicUdiDi>
    <tradeName>D-539154038FP-232-333EV</tradeName>
    <deviceName>PDGFRB gene break apart 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-232-3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:54.537Z</lastUpdated>
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    <udiDi>D-539154038FP-142ZH8B</udiDi>
    <basicUdiDi>B-539154038FP-142ZH8B</basicUdiDi>
    <tradeName>D-539154038FP-142ZH8B</tradeName>
    <deviceName>Del(11)(p15.5) (11p15.5) deletion probe reagent</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-142</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:51.150Z</lastUpdated>
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    <udiDi>D-539154038FP-094224E</udiDi>
    <basicUdiDi>B-539154038FP-094224E</basicUdiDi>
    <tradeName>D-539154038FP-094224E</tradeName>
    <deviceName>EWSR1/CREB1 gene fusion t(2;22) probe reagent</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-094</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:50.927Z</lastUpdated>
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    <udiDi>D-5391540380FP-412TD5X</udiDi>
    <basicUdiDi>B-5391540380FP-412TD5X</basicUdiDi>
    <tradeName>D-5391540380FP-412TD5X</tradeName>
    <deviceName>TP53 (17p13) gene break apart probe reagent</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-412</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:49.744Z</lastUpdated>
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    <udiDi>D-5391540380FP-410T94Z</udiDi>
    <basicUdiDi>B-5391540380FP-410T94Z</basicUdiDi>
    <tradeName>D-5391540380FP-410T94Z</tradeName>
    <deviceName>ESR1 (6q25) gene break apart probe reagent</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-410</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:48.441Z</lastUpdated>
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    <udiDi>D-5391540380FP-408TN7A</udiDi>
    <basicUdiDi>B-5391540380FP-408TN7A</basicUdiDi>
    <tradeName>D-5391540380FP-408TN7A</tradeName>
    <deviceName>PAX3/FOXO1 gene fusion t(2;13) probe reagent</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-408</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:45.655Z</lastUpdated>
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    <udiDi>D-5391540380FP-398UC8B</udiDi>
    <basicUdiDi>B-5391540380FP-398UC8B</basicUdiDi>
    <tradeName>D-5391540380FP-398UC8B</tradeName>
    <deviceName>CBFA2T3/GLIS2 gene fusion probe reagent</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-398</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:45.639Z</lastUpdated>
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    <udiDi>D-5391540380FP-386U56Y</udiDi>
    <basicUdiDi>B-5391540380FP-386U56Y</basicUdiDi>
    <tradeName>D-5391540380FP-386U56Y</tradeName>
    <deviceName>Chromosome 7 probe reagent (7q22/7q36/CEP7 tricolor )</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-386</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:43.217Z</lastUpdated>
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    <udiDi>D-5391540380FP-386-WPEB</udiDi>
    <basicUdiDi>B-5391540380FP-386-WPEB</basicUdiDi>
    <tradeName>D-5391540380FP-386-WPEB</tradeName>
    <deviceName>Chromosome 7 probe reagent (7q22/7q36/CEP7 tricolor )</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-386</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:42.528Z</lastUpdated>
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    <udiDi>D-5391540380FP-344TM75</udiDi>
    <basicUdiDi>B-5391540380FP-344TM75</basicUdiDi>
    <tradeName>D-5391540380FP-344TM75</tradeName>
    <deviceName>EGFR 7p probe reagent (7p11/CEP7)</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-344</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:38.614Z</lastUpdated>
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    <udiDi>D-5391540380FP-342-3ZLP3</udiDi>
    <basicUdiDi>B-5391540380FP-342-3ZLP3</basicUdiDi>
    <tradeName>D-5391540380FP-342-3ZLP3</tradeName>
    <deviceName>EWSR1/ERG GENE PROBE REAGENT</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-342-3</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:37.471Z</lastUpdated>
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    <udiDi>D-5391540380FP-370TN78</udiDi>
    <basicUdiDi>B-5391540380FP-370TN78</basicUdiDi>
    <tradeName>D-5391540380FP-370TN78</tradeName>
    <deviceName>Chromosome 20 probe reagent (20p11/20q12/20q13 tricolor )</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-370</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:37.420Z</lastUpdated>
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    <udiDi>D-5391540380FP-349TX8L</udiDi>
    <basicUdiDi>B-5391540380FP-349TX8L</basicUdiDi>
    <tradeName>D-5391540380FP-349TX8L</tradeName>
    <deviceName>PCM1/JAK2 gene fusion probe reagent</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-349</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:36.773Z</lastUpdated>
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    <tradeName>D-5391540380FP-342-2ZJNS</tradeName>
    <deviceName>EWSR1/CREB3L1 GENE PROBE REAGENT</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-342-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:19.378Z</lastUpdated>
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    <tradeName>D-5391540380FP-341TF68</tradeName>
    <deviceName>FLT3 gene break apart probe reagent</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-341</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:18.210Z</lastUpdated>
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    <tradeName>D-5391540380FP-340TD5X</tradeName>
    <deviceName>GATA2, MECOM (RPN1/MECOM) gene anomaly probe reagent</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-340</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:45:16.386Z</lastUpdated>
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