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    <manufacturerName>AVE Science &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031214</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:35:50.676Z</lastUpdated>
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    <tradeName>Liver Function Lyophilized Kit 14</tradeName>
    <deviceName>Liver Function Lyophilized Kit 14</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <tradeName>General Chemistry III Lyophilized Kit 15</tradeName>
    <deviceName>General Chemistry III Lyophilized Kit 15</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
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    <tradeName>Electrolyte &amp; Renal Function Lyophilized Kit 11</tradeName>
    <deviceName>Electrolyte &amp; Renal Function Lyophilized Kit 11</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
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    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:34:00.241Z</lastUpdated>
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    <udiDi>06950996050296</udiDi>
    <basicUdiDi>B-06950996050296</basicUdiDi>
    <tradeName>Clinical Emergency Lyophilized Kit 15</tradeName>
    <deviceName>Clinical Emergency Lyophilized Kit 15</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:54.241Z</lastUpdated>
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    <udiDi>06950996019323</udiDi>
    <basicUdiDi>B-06950996019323</basicUdiDi>
    <tradeName>Renal Function Glucose and Lipid Lyophilized Kit 10</tradeName>
    <deviceName>Renal Function Glucose and Lipid Lyophilized Kit 10</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KF-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:31.425Z</lastUpdated>
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    <udiDi>06950996012164</udiDi>
    <basicUdiDi>B-06950996012164</basicUdiDi>
    <tradeName>Myocardial Enzyme and Lipid Lyophilized Kit 10</tradeName>
    <deviceName>Myocardial Enzyme and Lipid Lyophilized Kit 10</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAR-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:23.006Z</lastUpdated>
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    <udiDi>06950996008808</udiDi>
    <basicUdiDi>B-06950996008808</basicUdiDi>
    <tradeName>General Chemistry II Lyophilized Kit 18</tradeName>
    <deviceName>General Chemistry II Lyophilized Kit 18</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYN-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:21.811Z</lastUpdated>
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    <udiDi>06950996006644</udiDi>
    <basicUdiDi>B-06950996006644</basicUdiDi>
    <tradeName>General Chemistry I Lyophilized Kit 18</tradeName>
    <deviceName>General Chemistry I Lyophilized Kit 18</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010404</emdnCode>
    <emdnDescription>MULTIPLE PARAMETERS (MIX OF ALL) - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYN-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:33:14.615Z</lastUpdated>
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    <udiDi>06950334816256</udiDi>
    <basicUdiDi>B-06950334816256</basicUdiDi>
    <tradeName>Electrolyte Reagent</tradeName>
    <deviceName>Electrolyte Reagent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42047001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:42:11.713Z</lastUpdated>
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    <basicUdiDi>B-06950334809524</basicUdiDi>
    <tradeName>Electrolyte Reagent</tradeName>
    <deviceName>Electrolyte Reagent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42048001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:41:23.267Z</lastUpdated>
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    <udiDi>06950334803225</udiDi>
    <basicUdiDi>B-06950334803225</basicUdiDi>
    <tradeName>Electrolyte Reagent</tradeName>
    <deviceName>Electrolyte Reagent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42043001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:17.640Z</lastUpdated>
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    <udiDi>06950334803218</udiDi>
    <basicUdiDi>B-06950334803218</basicUdiDi>
    <tradeName>Electrolyte Reagent</tradeName>
    <deviceName>Electrolyte Reagent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42044001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:15.386Z</lastUpdated>
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    <basicUdiDi>B-06950334803201</basicUdiDi>
    <tradeName>Electrolyte Reagent</tradeName>
    <deviceName>Electrolyte Reagent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42041001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:12.407Z</lastUpdated>
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    <udiDi>06950334803119</udiDi>
    <basicUdiDi>B-06950334803119</basicUdiDi>
    <tradeName>Electrolyte Reagent</tradeName>
    <deviceName>Electrolyte Reagent</deviceName>
    <manufacturerName>Genrui Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017351</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42035001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:39:10.021Z</lastUpdated>
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    <udiDi>06939663985109</udiDi>
    <basicUdiDi>B-06939663985109</basicUdiDi>
    <tradeName>URINALYSIS REAGENT STRIPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-022</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:05:17.393Z</lastUpdated>
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    <tradeName>URINALYSIS REAGENT STRIPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:05:16.221Z</lastUpdated>
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    <tradeName>URINALYSIS REAGENT STRIPS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010499</emdnCode>
    <emdnDescription>MULTIPLE CLIN. CHEM LAB REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>URS-140</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:05:14.996Z</lastUpdated>
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    <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>
    <emdnCode>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:04:41.134Z</lastUpdated>
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    <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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:04:39.928Z</lastUpdated>
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