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    <basicUdiDi>B-00810173656962</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Four Inflammatory Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1IF4B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:44.400Z</lastUpdated>
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    <udiDi>00810173656924</udiDi>
    <basicUdiDi>B-00810173656924</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Alpha-fetoprotein and Carcino-embryonic antigen (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM2B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:26.714Z</lastUpdated>
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    <udiDi>00810173656917</udiDi>
    <basicUdiDi>B-00810173656917</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Pepsinogen I, Pepsinogen II and Gastrin-17(Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1GF3B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:25.141Z</lastUpdated>
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    <udiDi>00810173656900</udiDi>
    <basicUdiDi>B-00810173656900</basicUdiDi>
    <tradeName>Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1AA15B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:22.715Z</lastUpdated>
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    <udiDi>00810173656894</udiDi>
    <basicUdiDi>B-00810173656894</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Six Tumor Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM6B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:21.120Z</lastUpdated>
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    <udiDi>00810173656887</udiDi>
    <basicUdiDi>B-00810173656887</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Seven Tumor Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM7B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:20.322Z</lastUpdated>
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    <udiDi>00810173656870</udiDi>
    <basicUdiDi>B-00810173656870</basicUdiDi>
    <tradeName>Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method)</tradeName>
    <deviceName>Quantitative Analysis Kit for Three Tumor Markers (Flowcytometry Fluorescence Method)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1TM3B01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:18.718Z</lastUpdated>
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    <udiDi>06944904032146</udiDi>
    <basicUdiDi>69449040004JD-Dimer****Q7</basicUdiDi>
    <tradeName>D-Dimer kit (Particle-enhanced Immunoturbidimetric Assay Method)</tradeName>
    <deviceName>D-Dimer kit (Particle-enhanced Immunoturbidimetric Assay Method)、D-Dimer Calibrator、D-Dimer Control</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002236-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:59.214Z</lastUpdated>
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    <udiDi>04050598016231</udiDi>
    <basicUdiDi>B-04050598016231</basicUdiDi>
    <tradeName>Thiolstatus</tradeName>
    <deviceName>Thiolstatus</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 1800DX</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:38.086Z</lastUpdated>
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    <udiDi>04050598118003</udiDi>
    <basicUdiDi>B-04050598118003</basicUdiDi>
    <tradeName>Thiolstatus</tradeName>
    <deviceName>Thiolstatus</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 1800</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.631Z</lastUpdated>
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    <udiDi>D-TA-L89408G2EE</udiDi>
    <basicUdiDi>B-TA-L89408G2EE</basicUdiDi>
    <tradeName>LIA-Diabetes-Profile</tradeName>
    <deviceName>LIA-Diabetes-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89408G2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:41.634Z</lastUpdated>
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    <udiDi>D-TA-L89408G1EC</udiDi>
    <basicUdiDi>B-TA-L89408G1EC</basicUdiDi>
    <tradeName>LIA-Diabetes-Profile</tradeName>
    <deviceName>LIA-Diabetes-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89408G1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:40.880Z</lastUpdated>
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    <udiDi>D-TA-L89407G2E9</udiDi>
    <basicUdiDi>B-TA-L89407G2E9</basicUdiDi>
    <tradeName>LIA-AAs Screen-Profile</tradeName>
    <deviceName>LIA-AAs Screen-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89407G2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:36.860Z</lastUpdated>
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    <udiDi>D-TA-L89407G1E7</udiDi>
    <basicUdiDi>B-TA-L89407G1E7</basicUdiDi>
    <tradeName>LIA-AAs Screen-Profile</tradeName>
    <deviceName>LIA-AAs Screen-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89407G1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:36.052Z</lastUpdated>
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    <udiDi>D-TA-L89404G-2AH</udiDi>
    <basicUdiDi>B-TA-L89404G-2AH</basicUdiDi>
    <tradeName>LIA-Liver-Profile</tradeName>
    <deviceName>LIA-Liver-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89404G-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:35.220Z</lastUpdated>
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    <udiDi>D-TA-L89403G2-2BE</udiDi>
    <basicUdiDi>B-TA-L89403G2-2BE</basicUdiDi>
    <tradeName>LIA-Vasculitis-Profile</tradeName>
    <deviceName>LIA-Vasculitis-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89403G2-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:34.422Z</lastUpdated>
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    <udiDi>D-TA-L89403G1-2B9</udiDi>
    <basicUdiDi>B-TA-L89403G1-2B9</basicUdiDi>
    <tradeName>LIA-Vasculitis-Profile</tradeName>
    <deviceName>LIA-Vasculitis-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89403G1-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:30.419Z</lastUpdated>
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    <udiDi>D-TA-L89401G4-2B2</udiDi>
    <basicUdiDi>B-TA-L89401G4-2B2</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89401G4-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:29.617Z</lastUpdated>
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    <udiDi>D-TA-L89401G3-2AV</udiDi>
    <basicUdiDi>B-TA-L89401G3-2AV</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89401G3-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:28.813Z</lastUpdated>
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    <udiDi>D-TA-L89401G2-2AQ</udiDi>
    <basicUdiDi>B-TA-L89401G2-2AQ</basicUdiDi>
    <tradeName>LIA-ANA-Profile</tradeName>
    <deviceName>LIA-ANA-Profile</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TA-L89401G2-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:28.036Z</lastUpdated>
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