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    <tradeName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×1  R2:20mL×1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:14.429Z</lastUpdated>
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    <udiDi>06971674860792</udiDi>
    <basicUdiDi>B-06971674860792</basicUdiDi>
    <tradeName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×1  R2:6mL×1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:13.801Z</lastUpdated>
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    <udiDi>06971674860785</udiDi>
    <basicUdiDi>B-06971674860785</basicUdiDi>
    <tradeName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:18mL×4  R2:6mL×4(709)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:13.031Z</lastUpdated>
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    <udiDi>06971674860778</udiDi>
    <basicUdiDi>B-06971674860778</basicUdiDi>
    <tradeName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>Apolipoprotein A1 (ApoA1) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60mL×2  R2:20mL×2(701)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:09:12.616Z</lastUpdated>
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    <udiDi>06971225933104</udiDi>
    <basicUdiDi>B-06971225933104</basicUdiDi>
    <tradeName>Nephstar Apo A1 Kit</tradeName>
    <deviceName>Nephstar Apo A1 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK041</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:26:34.316Z</lastUpdated>
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    <udiDi>06971225930769</udiDi>
    <basicUdiDi>B-06971225930769</basicUdiDi>
    <tradeName>Omlipo Apo A1 Kit</tradeName>
    <deviceName>Omlipo Apo A1 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP41050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:29.175Z</lastUpdated>
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    <udiDi>06944904025322</udiDi>
    <basicUdiDi>694490400041ApoA1******EC</basicUdiDi>
    <tradeName>Apolipoprotein A1 Kit (Turbidimetry Method)</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000876-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:11:01.795Z</lastUpdated>
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    <udiDi>06944904050805</udiDi>
    <basicUdiDi>694490400041ApoA1******EC</basicUdiDi>
    <tradeName>Apolipoprotein A1 Kit (Turbidimetry Method)</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 B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004602-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:28.969Z</lastUpdated>
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    <udiDi>00816426020016</udiDi>
    <basicUdiDi>B-00816426020016</basicUdiDi>
    <tradeName>K-ASSAY Apo AI</tradeName>
    <deviceName>Apo AI Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:14.685Z</lastUpdated>
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    <udiDi>06935740733441</udiDi>
    <basicUdiDi>69357407ICAS000037B5</basicUdiDi>
    <tradeName>06935740733441</tradeName>
    <deviceName>Apolipoprotein A1 (Apo A1) Assay Kit (Immunoturbidimetric Assay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:20.981Z</lastUpdated>
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    <udiDi>16438153819292</udiDi>
    <basicUdiDi>6438153BU00173BZ</basicUdiDi>
    <tradeName>Apolipoprotein A1</tradeName>
    <deviceName>Apolipoprotein A1</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981929</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:08:02.625Z</lastUpdated>
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    <udiDi>00842768011269</udiDi>
    <basicUdiDi>0405686900940VU</basicUdiDi>
    <tradeName>N Antiserum to Human Apolipoprotein A-I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446438</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T19:51:10.707Z</lastUpdated>
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    <udiDi>06941967204367</udiDi>
    <basicUdiDi>B-06941967204367</basicUdiDi>
    <tradeName>06941967204367</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.02.06.EC.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:47:09.350Z</lastUpdated>
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    <udiDi>06936595750195</udiDi>
    <basicUdiDi>B-06936595750195</basicUdiDi>
    <tradeName>Apolipoprotein A-I Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ401Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:53:49.758Z</lastUpdated>
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    <basicUdiDi>69357407ICAS000037B5</basicUdiDi>
    <tradeName>06935740739412</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:04:35.111Z</lastUpdated>
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    <basicUdiDi>69357407ICAS000037B5</basicUdiDi>
    <tradeName>06935740733489</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:03:18.351Z</lastUpdated>
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    <basicUdiDi>69357407ICAS000037B5</basicUdiDi>
    <tradeName>06935740733472</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:03:17.056Z</lastUpdated>
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    <tradeName>06935740733465</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:03:16.108Z</lastUpdated>
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    <basicUdiDi>69357407ICAS000037B5</basicUdiDi>
    <tradeName>06935740733458</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:03:14.766Z</lastUpdated>
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    <basicUdiDi>B-06438115000488</basicUdiDi>
    <tradeName>APO A-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>67265</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:58.152Z</lastUpdated>
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