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    <tradeName>Prealbumin Kit（Turbidimetry Method）</tradeName>
    <deviceName>Prealbumin Kit (Turbidimetry Method)、Prealbumin Calibrator</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-31T16:43:33.885Z</lastUpdated>
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    <tradeName>AutoChem PA</tradeName>
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    <manufacturerName>Autobio Biochemistry Co.,Ltd</manufacturerName>
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    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <tradeName>IDK® Präalbumin ELISA</tradeName>
    <deviceName>IDK® Präalbumin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>PREALBUMIN IP</tradeName>
    <deviceName>PREALBUMIN IP</deviceName>
    <manufacturerName>VitalScientific</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPAL-0400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:51:33.704Z</lastUpdated>
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    <udiDi>15099590010706</udiDi>
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    <tradeName>Prealbumin</tradeName>
    <deviceName>Prealbumin</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6175</reference>
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    <lastUpdated>2026-07-30T17:28:56.857Z</lastUpdated>
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    <tradeName>IMMAGE Immunochemistry Systems PAB Prealbumin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems PAB Prealbumin Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>00842768006210</udiDi>
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    <tradeName>Dimension Vista Prealbumin Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_MAR EB_B_KIT_V_PREALB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
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    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445906</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:25:33.000Z</lastUpdated>
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    <tradeName>PRE-ALBUMIN</tradeName>
    <deviceName>Pre-Albumin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK1102124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:22:37.935Z</lastUpdated>
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    <tradeName>PRE-ALBUMIN</tradeName>
    <deviceName>Pre-Albumin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:21:05.014Z</lastUpdated>
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    <udiDi>08431673088217</udiDi>
    <basicUdiDi>B-08431673088217</basicUdiDi>
    <tradeName>PRE-ALBUMIN</tradeName>
    <deviceName>Pre-albumin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JL1102124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:17:15.860Z</lastUpdated>
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    <udiDi>D-R0611523</udiDi>
    <basicUdiDi>B-R0611523</basicUdiDi>
    <tradeName>D-R0611523</tradeName>
    <deviceName>Pre-albumin Assay Reagent Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06115</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:03.268Z</lastUpdated>
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    <udiDi>D-R06114ZW</udiDi>
    <basicUdiDi>B-R06114ZW</basicUdiDi>
    <tradeName>D-R06114ZW</tradeName>
    <deviceName>Pre-albumin Assay Reagent Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06114</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:02.458Z</lastUpdated>
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    <udiDi>D-R0611625</udiDi>
    <basicUdiDi>B-R0611625</basicUdiDi>
    <tradeName>D-R0611625</tradeName>
    <deviceName>Pre-albumin Assay Reagent Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06116</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:00.856Z</lastUpdated>
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    <udiDi>D-R06113ZU</udiDi>
    <basicUdiDi>B-R06113ZU</basicUdiDi>
    <tradeName>D-R06113ZU</tradeName>
    <deviceName>Pre-albumin Assay Reagent Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06113</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:54:43.967Z</lastUpdated>
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    <tradeName>D-R06112ZS</tradeName>
    <deviceName>Pre-albumin Assay Reagent Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>D-R06111ZQ</udiDi>
    <basicUdiDi>B-R06111ZQ</basicUdiDi>
    <tradeName>D-R06111ZQ</tradeName>
    <deviceName>In vitro test for the quantitative determination of prealbumin concentration in serum.</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06111</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:54:42.364Z</lastUpdated>
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    <udiDi>D-6-41A8</udiDi>
    <basicUdiDi>B-6-41A8</basicUdiDi>
    <tradeName>D-6-41A8</tradeName>
    <deviceName>Prealbumin Test 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: U81282040M, U81289040M, U81285020M, U81211020M, U81220040M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:12:54.028Z</lastUpdated>
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    <udiDi>D-59H40TXN</udiDi>
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    <tradeName>Prealbumin (PA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Prealbumin (PA) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>59H40T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:07.981Z</lastUpdated>
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    <tradeName>Prealbumin (PA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Prealbumin (PA) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>59H40TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:06.698Z</lastUpdated>
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    <udiDi>D-59H160TSCC9</udiDi>
    <basicUdiDi>B-59H160TSCC9</basicUdiDi>
    <tradeName>Prealbumin (PA) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Prealbumin (PA) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010305</emdnCode>
    <emdnDescription>PRE-ALBUMIN / TRANSTHYRETIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>59H160TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:06:05.718Z</lastUpdated>
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