<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00630414177168</udiDi>
    <basicUdiDi>0405686901638VZ</basicUdiDi>
    <tradeName>ADVIA Centaur® VB12</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_KIT_VB12</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10309970</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:32:44.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414976624</udiDi>
    <basicUdiDi>0405686900207UT</basicUdiDi>
    <tradeName>Dimension EXL LOCI Vitamin B12 Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_VB12</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10463371</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:04:43.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414962313</udiDi>
    <basicUdiDi>0405686900229V5</basicUdiDi>
    <tradeName>IMMULITE 2000 Vitamin B12</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_Vitamin B12</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380914</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:03:39.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID128F3</udiDi>
    <basicUdiDi>B-VID128F3</basicUdiDi>
    <tradeName>VivaDiag Vitamin B12 Test Kit (FIA)</tradeName>
    <deviceName>VivaDiag Vitamin B12 Test Kit (FIA)</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>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID128-07-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:20:21.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VB12706-AECK</udiDi>
    <basicUdiDi>B-VB12706-AECK</basicUdiDi>
    <tradeName>Vitamin B12 (CLIA)</tradeName>
    <deviceName>Vitamin B12 (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VB12706-AE10Y, VB12706-AE10N, VB12706-AE20Y, VB12706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:13:06.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-123U</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-123U</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-123U</tradeName>
    <deviceName>Vitamin B12 Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:55:46.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK020DC</udiDi>
    <basicUdiDi>B-SEK020DC</basicUdiDi>
    <tradeName>Vitamin B₁₂ Assay Kit (ECLIA)</tradeName>
    <deviceName>Vitamin B₁₂ Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:56.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20215ZH</udiDi>
    <basicUdiDi>B-R20215ZH</basicUdiDi>
    <tradeName>D-R20215ZH</tradeName>
    <deviceName>Vitamin B12 (Vit B12) Reagent Kit (Chemiluminescent Immunoassay)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:19.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20214ZF</udiDi>
    <basicUdiDi>B-R20214ZF</basicUdiDi>
    <tradeName>D-R20214ZF</tradeName>
    <deviceName>Vitamin B12 (Vit B12) Reagent Kit (Chemiluminescent Immunoassay)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:18.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20213ZD</udiDi>
    <basicUdiDi>B-R20213ZD</basicUdiDi>
    <tradeName>D-R20213ZD</tradeName>
    <deviceName>Vitamin B12 (Vit B12) Reagent Kit (Chemiluminescent Immunoassay)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20213</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:17.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20212ZB</udiDi>
    <basicUdiDi>B-R20212ZB</basicUdiDi>
    <tradeName>D-R20212ZB</tradeName>
    <deviceName>Vitamin B12 (Vit B12) Reagent Kit (Chemiluminescent Immunoassay)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20212</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:01.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20211Z9</udiDi>
    <basicUdiDi>B-R20211Z9</basicUdiDi>
    <tradeName>D-R20211Z9</tradeName>
    <deviceName>Vitamin B12 (Vit B12) Reagent Kit (Chemiluminescent Immunoassay)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:25:00.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800111722905</udiDi>
    <basicUdiDi>88001117IPBA01IA18WA</basicUdiDi>
    <tradeName>STANDARD™ i Vitamin B12</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16VITB10F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:29.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403212HN</udiDi>
    <basicUdiDi>B-IM4403212HN</basicUdiDi>
    <tradeName>D-IM4403212HN</tradeName>
    <deviceName>VB12 Chemiluminescent Binding Assay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403212</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:47.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402212HF</udiDi>
    <basicUdiDi>B-IM4402212HF</basicUdiDi>
    <tradeName>D-IM4402212HF</tradeName>
    <deviceName>VB12 Chemiluminescent Binding Assay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402212</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:18:37.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD191XT</udiDi>
    <basicUdiDi>B-GKPD191XT</basicUdiDi>
    <tradeName>VB12 Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>VB12 Detection Kit (Immunofluorescence Chromatography)</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD191</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:53.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIVB12-302aN2</udiDi>
    <basicUdiDi>B-FIVB12-302aN2</basicUdiDi>
    <tradeName>Vitamin B12 Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>Vitamin B12 Quantitative Test Kit (Time-Resolved FIA)</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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIVB12-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:36.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FIVB12-302aHGRE</udiDi>
    <basicUdiDi>B-FIVB12-302aHGRE</basicUdiDi>
    <tradeName>Vitamin B12 Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></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>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIVB12-302a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:33:36.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT012577</udiDi>
    <basicUdiDi>B-DT012577</basicUdiDi>
    <tradeName>Unicorn-Vitamin B12</tradeName>
    <deviceName>Unicorn-Vitamin B12</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:16:42.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DT012475</udiDi>
    <basicUdiDi>B-DT012475</basicUdiDi>
    <tradeName>Unicorn-Vitamin B12</tradeName>
    <deviceName>Unicorn-Vitamin B12</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DT0124</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:16:40.906Z</lastUpdated>
  </row>
</eudamedExport>