<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-VIC7539</udiDi>
    <basicUdiDi>B-VIC7539</basicUdiDi>
    <tradeName>Pregnanediol-3-Glucuronide Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC75-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:19.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC683C</udiDi>
    <basicUdiDi>B-VIC683C</basicUdiDi>
    <tradeName>Aldosterone Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC68-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:17.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC6638</udiDi>
    <basicUdiDi>B-VIC6638</basicUdiDi>
    <tradeName>Adrenocorticotropic Hormone Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC66-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:15.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC6434</udiDi>
    <basicUdiDi>B-VIC6434</basicUdiDi>
    <tradeName>Free Triiodothyronine Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC64-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:13.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC6332</udiDi>
    <basicUdiDi>B-VIC6332</basicUdiDi>
    <tradeName>Free Thyroxine Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC63-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:13.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC593B</udiDi>
    <basicUdiDi>B-VIC593B</basicUdiDi>
    <tradeName>Gastrin-17 Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC59-06-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:07.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC5635</udiDi>
    <basicUdiDi>B-VIC5635</basicUdiDi>
    <tradeName>Testosterone Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC56-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:02.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC5533</udiDi>
    <basicUdiDi>B-VIC5533</basicUdiDi>
    <tradeName>Progesterone Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC55-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:19:01.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC322P</udiDi>
    <basicUdiDi>B-VIC322P</basicUdiDi>
    <tradeName>Prolactin Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC32-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:52.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC302K</udiDi>
    <basicUdiDi>B-VIC302K</basicUdiDi>
    <tradeName>VivaDiag Anti-Mullerian Hormone Control Solution (FIA)</tradeName>
    <deviceName>VivaDiag Anti-Mullerian Hormone Control Solution (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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC30-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:49.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC232N</udiDi>
    <basicUdiDi>B-VIC232N</basicUdiDi>
    <tradeName>VivaDiag Luteinising Hormone Control Solution (FIA)</tradeName>
    <deviceName>VivaDiag Luteinising Hormone Control Solution (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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC23-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:41.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC212J</udiDi>
    <basicUdiDi>B-VIC212J</basicUdiDi>
    <tradeName>VivaDiag Triiodothyronine Control Solution (FIA)</tradeName>
    <deviceName>VivaDiag Triiodothyronine Control Solution (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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC21-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:39.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC222L</udiDi>
    <basicUdiDi>B-VIC222L</basicUdiDi>
    <tradeName>VivaDiag Thyroxine Control Solution (FIA)</tradeName>
    <deviceName>VivaDiag Thyroxine Control Solution (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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC22-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:37.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC202G</udiDi>
    <basicUdiDi>B-VIC202G</basicUdiDi>
    <tradeName>VivaDiag Thyroid Stimulating Hormone Control Solution (FIA)</tradeName>
    <deviceName>VivaDiag Thyroid Stimulating Hormone Control Solution (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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC20-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:23.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC192X</udiDi>
    <basicUdiDi>B-VIC192X</basicUdiDi>
    <tradeName>Beta Human Chorionic Gonadotropin Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC19-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:21.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC182V</udiDi>
    <basicUdiDi>B-VIC182V</basicUdiDi>
    <tradeName>VivaDiag Insulin Control Solution (FIA)</tradeName>
    <deviceName>VivaDiag Insulin Control Solution (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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC18-04-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:19.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC172T</udiDi>
    <basicUdiDi>B-VIC172T</basicUdiDi>
    <tradeName>VivaDiag C-peptide Control Solution (FIA)</tradeName>
    <deviceName>VivaDiag C-peptide Control Solution (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>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC17-04-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:18:18.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIC146EW</udiDi>
    <basicUdiDi>B-VIC146EW</basicUdiDi>
    <tradeName>17α-Hydroxyprogesterone Control Solution (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>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIC146-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:17:59.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-T4HP123V5</udiDi>
    <basicUdiDi>B-T4HP123V5</basicUdiDi>
    <tradeName>T4 Control</tradeName>
    <deviceName>T4 Control</deviceName>
    <manufacturerName>Heavybio,Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000049958</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP123-7F, HP123-8F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:53:45.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SexHormoneCONYK</udiDi>
    <basicUdiDi>B-SexHormoneCONYK</basicUdiDi>
    <tradeName>Sex Hormone (Lyophilized) Control</tradeName>
    <deviceName>Sex Hormone (Lyophilized) Control</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sex Hormone CON</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:48:53.411Z</lastUpdated>
  </row>
</eudamedExport>