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    <tradeName>Leukemia PML-RARa Fusion Gene Typing Real Time RT-PCR Kit</tradeName>
    <deviceName>Leukemia PML-RARa Fusion Gene Typing Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0280-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:02:06.541Z</lastUpdated>
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    <udiDi>06971042228674</udiDi>
    <basicUdiDi>B-06971042228674</basicUdiDi>
    <tradeName>Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit</tradeName>
    <deviceName>Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0126-08</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:02:03.984Z</lastUpdated>
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    <udiDi>06971042228667</udiDi>
    <basicUdiDi>B-06971042228667</basicUdiDi>
    <tradeName>Leukemia mu-BCR Fusion Gene Real Time RT-PCR Kit</tradeName>
    <deviceName>Leukemia mu-BCR Fusion Gene Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0126-06</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:02:02.361Z</lastUpdated>
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    <udiDi>06971042228650</udiDi>
    <basicUdiDi>B-06971042228650</basicUdiDi>
    <tradeName>Leukemia m-BCR Fusion Gene Real Time RT-PCR Kit</tradeName>
    <deviceName>Leukemia m-BCR Fusion Gene Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0126-04</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:02:01.579Z</lastUpdated>
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    <udiDi>06971042228643</udiDi>
    <basicUdiDi>B-06971042228643</basicUdiDi>
    <tradeName>Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit</tradeName>
    <deviceName>Leukemia BCR-ABL Fusion Gene Typing Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0126-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:02:00.221Z</lastUpdated>
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  <row>
    <udiDi>06971042225154</udiDi>
    <basicUdiDi>B-06971042225154</basicUdiDi>
    <tradeName>8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit</tradeName>
    <deviceName>8 Common Leukemia Fusion Genes Screening Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080105</emdnCode>
    <emdnDescription>ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&amp;T-CELL TYPING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-0299-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:56:58.121Z</lastUpdated>
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    <udiDi>06944904052403</udiDi>
    <basicUdiDi>69449040XQSJ-003Xhemo**HV</basicUdiDi>
    <tradeName>Sheath Fluid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005731-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:28.050Z</lastUpdated>
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    <udiDi>06944904052410</udiDi>
    <basicUdiDi>69449040XQSJ-003Xhemo**HV</basicUdiDi>
    <tradeName>Cleaning Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>AUXILIARY &amp; SUPPLEMENTAL REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005732-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:27.980Z</lastUpdated>
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    <udiDi>06944904053981</udiDi>
    <basicUdiDi>69449040XQSJ-003Xhemo**HV</basicUdiDi>
    <tradeName>Eluent A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007852-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.586Z</lastUpdated>
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    <udiDi>06944904053998</udiDi>
    <basicUdiDi>69449040XQSJ-003Xhemo**HV</basicUdiDi>
    <tradeName>Eluent B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007854-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.564Z</lastUpdated>
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    <udiDi>06944904054001</udiDi>
    <basicUdiDi>69449040XQSJ-003Xhemo**HV</basicUdiDi>
    <tradeName>Eluent B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007853-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.536Z</lastUpdated>
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    <udiDi>06944904054018</udiDi>
    <basicUdiDi>69449040XQSJ-003Xhemo**HV</basicUdiDi>
    <tradeName>Eluent B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007855-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.506Z</lastUpdated>
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    <udiDi>06944904054025</udiDi>
    <basicUdiDi>69449040XQSJ-003Xhemo**HV</basicUdiDi>
    <tradeName>Hemolysis Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103080599</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-007856-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.474Z</lastUpdated>
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    <udiDi>04050598000551</udiDi>
    <basicUdiDi>B-04050598000551</basicUdiDi>
    <tradeName>Immunglobulin G ELISA</tradeName>
    <deviceName>Immunglobulin G ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080202</emdnCode>
    <emdnDescription>IGA, IGD, IGM, IGG, IGE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6510A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:39:52.612Z</lastUpdated>
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    <udiDi>03770026177006</udiDi>
    <basicUdiDi>B-03770026177006</basicUdiDi>
    <tradeName>METAglut1</tradeName>
    <deviceName>METAglut1</deviceName>
    <manufacturerName>METAFORA biosystems</manufacturerName>
    <manufacturerSrn>FR-MF-000004551</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080699</emdnCode>
    <emdnDescription>REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG1-10T6</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:33:20.338Z</lastUpdated>
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    <udiDi>D-0186P</udiDi>
    <basicUdiDi>B-0186P</basicUdiDi>
    <tradeName>D-0186P</tradeName>
    <deviceName>Sperm Nuclear DNA Integrity Kit</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080699</emdnCode>
    <emdnDescription>REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>310601HNE,310602HNE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:10:02.830Z</lastUpdated>
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    <basicUdiDi>B-0176M</basicUdiDi>
    <tradeName>D-0176M</tradeName>
    <deviceName>Easycount Tubes</deviceName>
    <manufacturerName>Hunan Wellgrow Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045201</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103080699</emdnCode>
    <emdnDescription>REAGENTS FOR FLOW CYTOMETRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>330102HNE,330103HNE</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:09:52.414Z</lastUpdated>
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    <tradeName>Not Applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
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    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103080199</emdnCode>
    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>333143</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:16.735Z</lastUpdated>
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    <tradeName>Not Applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
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    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>339216</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:16.714Z</lastUpdated>
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    <tradeName>Not Applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Becton, Dickinson and Company, BD Biosciences</manufacturerName>
    <manufacturerSrn>US-MF-000017797</manufacturerSrn>
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    <emdnDescription>MONOCLONAL ANTIBODIES FOR CELL SURFACE ANTIGENS - OTHER</emdnDescription>
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    <reference>347403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:15.779Z</lastUpdated>
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