<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DC76015F8</udiDi>
    <basicUdiDi>B-DC76015F8</basicUdiDi>
    <tradeName>iStar-25-OH Vitamin D</tradeName>
    <deviceName>iStar-25-OH Vitamin D</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:02:42.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808174QR</udiDi>
    <basicUdiDi>B-808174QR</basicUdiDi>
    <tradeName>D-808174QR</tradeName>
    <deviceName>25-OH Vitamin D Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808174</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:14.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-808173QP</udiDi>
    <basicUdiDi>B-808173QP</basicUdiDi>
    <tradeName>D-808173QP</tradeName>
    <deviceName>25-OH VD Rapid Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:55:13.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7M12F3</udiDi>
    <basicUdiDi>B-7M12F3</basicUdiDi>
    <tradeName>25-Hydroxy Vitamin D assay (CLIA)</tradeName>
    <deviceName>25-Hydroxy Vitamin D assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7M12V1-B-EU, 7M12U1-B-EU, 7M12P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:36.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067100</udiDi>
    <basicUdiDi>69703416803205150JF</basicUdiDi>
    <tradeName>25-OH Vitamin D Total II (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>693121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:12:06.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067124</udiDi>
    <basicUdiDi>69703416803205150JF</basicUdiDi>
    <tradeName>25-OH Vitamin D Total II (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>693124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:12:05.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975984067117</udiDi>
    <basicUdiDi>69703416803205150JF</basicUdiDi>
    <tradeName>25-OH Vitamin D Total II (Electrochemiluminescence Immunoassay)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>693125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:12:05.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-3025A4</udiDi>
    <basicUdiDi>B-3025A4</basicUdiDi>
    <tradeName>D-3025A4</tradeName>
    <deviceName>25-OH-Vitamin D in vitro diagnostic kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Aikang Diagnostics Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028962</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKBR3025030</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:29.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-25-OHVD706-AESU</udiDi>
    <basicUdiDi>B-25-OHVD706-AESU</basicUdiDi>
    <tradeName>25-OH Vitamin D Total (CLIA)</tradeName>
    <deviceName>25-OH Vitamin D Total (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>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25-OHVD706-AE10Y, 25-OHVD706-AE10N, 25-OHVD706-AE20Y, 25-OHVD706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:47:32.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>20850076346410</udiDi>
    <basicUdiDi>B-20850076346410</basicUdiDi>
    <tradeName>25-OH-Vitamin D Test Kit (CLIA)</tradeName>
    <deviceName>25-OH-Vitamin D Test Kit (CLIA)</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CIVD-301a</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:03:27.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723110</udiDi>
    <basicUdiDi>692591270020GP</basicUdiDi>
    <tradeName>iFlash-25-OH Vitamin D</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86319</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:09.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912724308</udiDi>
    <basicUdiDi>692591270278HY</basicUdiDi>
    <tradeName>iFlash-25-OH Vitamin D Ⅱ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86326-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912734482</udiDi>
    <basicUdiDi>692591270278HY</basicUdiDi>
    <tradeName>iFlash-25-OH Vitamin D Ⅱ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86326-L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763532</udiDi>
    <basicUdiDi>B-15065023763532</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>25-OH-VD Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20015</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:35:49.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763327</udiDi>
    <basicUdiDi>B-15065023763327</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>25-hydroxy vitamin D Rapid Test (LFA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV10033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:34:59.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189215006</udiDi>
    <basicUdiDi>B-14560189215006</basicUdiDi>
    <tradeName>14560189215006</tradeName>
    <deviceName>CL AIA-PACK 25-OH Vitamin D PRETREATMENT CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029546</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:51.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189214993</udiDi>
    <basicUdiDi>B-14560189214993</basicUdiDi>
    <tradeName>14560189214993</tradeName>
    <deviceName>CL AIA-PACK 25-OH Vitamin D ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029246</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:50.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189214986</udiDi>
    <basicUdiDi>B-14560189214986</basicUdiDi>
    <tradeName>14560189214986</tradeName>
    <deviceName>CL AIA-PACK 25-OH Vitamin D TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029146</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:50.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>14560189213125</udiDi>
    <basicUdiDi>B-14560189213125</basicUdiDi>
    <tradeName>14560189213125</tradeName>
    <deviceName>ST AIA-PACK 25-OH Vitamin D</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0025234</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:02:24.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-12M87</udiDi>
    <basicUdiDi>B-12M87</basicUdiDi>
    <tradeName>D-12M87</tradeName>
    <deviceName>25-Hydroxyvitamin D Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:56:58.165Z</lastUpdated>
  </row>
</eudamedExport>