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    <deviceName>MDS chromosome and gene anomaly probe detection kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
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    <lastUpdated>2026-08-06T05:29:00.166Z</lastUpdated>
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    <tradeName>D-06971808258174VP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
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    <deviceName></deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
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    <deviceName></deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <reference>FP-014-1</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
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    <tradeName>06971808257719</tradeName>
    <deviceName>MDS chromosome and gene anomaly probe detection kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-011-2</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-06T03:59:43.323Z</lastUpdated>
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    <tradeName>D-697180825KFP009HCWE</tradeName>
    <deviceName>Bladder Cancer Cells chromosome and gene anomaly probe detection kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-009</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:31:30.560Z</lastUpdated>
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    <deviceName>RARA (17q21) probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:31:29.803Z</lastUpdated>
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    <deviceName>AML1/ETO gene fusion detection kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-004</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:31:25.762Z</lastUpdated>
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    <deviceName>Human HER2 gene amplification detection kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060213</emdnCode>
    <emdnDescription>HER-2/NEU (BREAST CANCER)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-001</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:31:24.951Z</lastUpdated>
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    <deviceName>BCR/ABL gene fusion detection kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060208</emdnCode>
    <emdnDescription>T (9;22)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-08-05T22:31:24.157Z</lastUpdated>
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    <deviceName>Washing Solution</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030799</emdnCode>
    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-007</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:21:55.944Z</lastUpdated>
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    <deviceName>Washing Solution</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-009-6</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-26T22:58:40.665Z</lastUpdated>
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    <deviceName>Washing Solution</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:05:13.628Z</lastUpdated>
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    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>CCND1 (BCL1) gene break apart probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
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    <reference>FP-042</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:08:58.017Z</lastUpdated>
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    <deviceName>6q probe reagent</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
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    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:04:29.819Z</lastUpdated>
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    <tradeName>Fast Fluorescence In Situ Hybridization Probe Kit</tradeName>
    <deviceName>Human ALK gene fusion detection probe</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:04:29.014Z</lastUpdated>
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    <deviceName>FISH Sample Processing Kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-020</reference>
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    <lastUpdated>2026-07-02T09:17:37.110Z</lastUpdated>
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    <deviceName>In Situ Hybridization Staining Solution</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-012-1</reference>
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    <lastUpdated>2026-07-02T09:17:36.300Z</lastUpdated>
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    <deviceName>Automated FISH Slide Scanning System</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0299</emdnCode>
    <emdnDescription>IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FF-S2400</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
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    <deviceName>FISH Pretreatment Reagent Kit</deviceName>
    <manufacturerName>Wuhan HealthCare Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033113</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
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    <emdnDescription>HISTOLOGY / CYTOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:17:29.895Z</lastUpdated>
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