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    <basicUdiDi>B-06974323011705</basicUdiDi>
    <tradeName>06974323011705</tradeName>
    <deviceName>Vitamin D rapid test cassette (Rare earth nano fluorescence immunochromatography)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:48:12.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465231557</udiDi>
    <basicUdiDi>697846523VitaminB01LB</basicUdiDi>
    <tradeName>25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:34:16.861Z</lastUpdated>
  </row>
  <row>
    <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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  <row>
    <udiDi>06933260207954</udiDi>
    <basicUdiDi>B-06933260207954</basicUdiDi>
    <tradeName>25(OH)-D 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>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT2801</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:00.763Z</lastUpdated>
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  <row>
    <udiDi>06933260206568</udiDi>
    <basicUdiDi>B-06933260206568</basicUdiDi>
    <tradeName>BIOTIME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0504505</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:57:01.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206551</udiDi>
    <basicUdiDi>B-06933260206551</basicUdiDi>
    <tradeName>BIOTIME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0504504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:57:00.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206544</udiDi>
    <basicUdiDi>B-06933260206544</basicUdiDi>
    <tradeName>BIOTIME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0504503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:59.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206537</udiDi>
    <basicUdiDi>B-06933260206537</basicUdiDi>
    <tradeName>BIOTIME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0504502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:57.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933260206520</udiDi>
    <basicUdiDi>B-06933260206520</basicUdiDi>
    <tradeName>BIOTIME</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0504501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:56:55.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414649870</udiDi>
    <basicUdiDi>0405686902369W4</basicUdiDi>
    <tradeName>Atellica IM Vitamin D Total II (VitDII)</tradeName>
    <deviceName></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>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11698629</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:05:58.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465231601</udiDi>
    <basicUdiDi>697846523VitaminB01LB</basicUdiDi>
    <tradeName>25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:39:05.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465238051</udiDi>
    <basicUdiDi>697846523VitaminB01LB</basicUdiDi>
    <tradeName>25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:49.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465238068</udiDi>
    <basicUdiDi>697846523VitaminB01LB</basicUdiDi>
    <tradeName>25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:49.220Z</lastUpdated>
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  <row>
    <udiDi>06978465238075</udiDi>
    <basicUdiDi>697846523VitaminB01LB</basicUdiDi>
    <tradeName>25-hydroxy Vitamin D Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102070206</emdnCode>
    <emdnDescription>VITAMIN D (CHOLECALCIFEROL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T08:38:49.207Z</lastUpdated>
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