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    <basicUdiDi>B-06941967225027</basicUdiDi>
    <tradeName>06941967225027</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.4E.01.01.02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:48:53.642Z</lastUpdated>
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    <udiDi>06941967223603</udiDi>
    <basicUdiDi>B-06941967223603</basicUdiDi>
    <tradeName>06941967223603</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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.0A.00.EC.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T17:48:27.438Z</lastUpdated>
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    <udiDi>06939716405479</udiDi>
    <basicUdiDi>693971640905ME</basicUdiDi>
    <tradeName>HOKAPI™ FOLATE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010905601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:59.505Z</lastUpdated>
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    <udiDi>06939716405455</udiDi>
    <basicUdiDi>693971640902M8</basicUdiDi>
    <tradeName>HOKAPI™ VITAMIN B12</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010902601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:57.132Z</lastUpdated>
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  <row>
    <udiDi>06939716405264</udiDi>
    <basicUdiDi>69713904309018H</basicUdiDi>
    <tradeName>HOKAPI™ FERRITIN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Suzhou Hokapi Biomedical Engineering Co., Ltd..</manufacturerName>
    <manufacturerSrn>CN-MF-000013723</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>010901601</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:07:35.474Z</lastUpdated>
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    <udiDi>06937339209191</udiDi>
    <basicUdiDi>B-06937339209191</basicUdiDi>
    <tradeName>Vitamin B12 Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID128-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:55:50.545Z</lastUpdated>
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  <row>
    <udiDi>06937339205087</udiDi>
    <basicUdiDi>B-06937339205087</basicUdiDi>
    <tradeName>VivaDiag Folate Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID129-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:44.467Z</lastUpdated>
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  <row>
    <udiDi>06937339205070</udiDi>
    <basicUdiDi>B-06937339205070</basicUdiDi>
    <tradeName>VivaDiag Vitamin B12 Test Kit (FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID128-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:43.263Z</lastUpdated>
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    <udiDi>06937287300216</udiDi>
    <basicUdiDi>B-06937287300216</basicUdiDi>
    <tradeName>06937287300216</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen AmTech Bioengineering Ltd., Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000043067</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1: 2×60 mL, R2: 2×20 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:51:34.798Z</lastUpdated>
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  <row>
    <udiDi>06936595751666</udiDi>
    <basicUdiDi>B-06936595751666</basicUdiDi>
    <tradeName>Vitamin B12 Kit (CLIA)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1453Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:25.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751659</udiDi>
    <basicUdiDi>B-06936595751659</basicUdiDi>
    <tradeName>Folate  Kit (CLIA)</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>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1452Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:23.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595751383</udiDi>
    <basicUdiDi>B-06936595751383</basicUdiDi>
    <tradeName>Ferritin Kit(CLIA)</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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1217Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:56:42.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936595750874</udiDi>
    <basicUdiDi>B-06936595750874</basicUdiDi>
    <tradeName>Total Iron Binding Capacity Kit (Ferrozine 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>W0102070107</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ465Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:55:30.639Z</lastUpdated>
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    <udiDi>06936595750768</udiDi>
    <basicUdiDi>B-06936595750768</basicUdiDi>
    <tradeName>Ferritin Kit (Latex-Enhanced 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>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ453Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:55:15.025Z</lastUpdated>
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    <udiDi>06936595750188</udiDi>
    <basicUdiDi>B-06936595750188</basicUdiDi>
    <tradeName>Iron Kit  (Ferrozine  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>W0102070106</emdnCode>
    <emdnDescription>IRON (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJ309Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:53:48.566Z</lastUpdated>
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    <udiDi>06936415917586</udiDi>
    <basicUdiDi>69449040004JFER********AD</basicUdiDi>
    <tradeName>Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay 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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-006176-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:25:24.707Z</lastUpdated>
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    <udiDi>06933289829632</udiDi>
    <basicUdiDi>B-06933289829632</basicUdiDi>
    <tradeName>Finecare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WX01P0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:06:59.483Z</lastUpdated>
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    <udiDi>06933289810463</udiDi>
    <basicUdiDi>B-06933289810463</basicUdiDi>
    <tradeName>Finecare</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangzhou Wondfo Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000000689</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W269P0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:06:13.847Z</lastUpdated>
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    <udiDi>06933260208692</udiDi>
    <basicUdiDi>B-06933260208692</basicUdiDi>
    <tradeName>BIOTIME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT2801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:34.031Z</lastUpdated>
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    <udiDi>06933260208562</udiDi>
    <basicUdiDi>B-06933260208562</basicUdiDi>
    <tradeName>Ferritin Rapid Quantitative Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT2701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:00:19.624Z</lastUpdated>
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