<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06952804802455</udiDi>
    <basicUdiDi>B-06952804802455</basicUdiDi>
    <tradeName>Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Squamous Cell Carcinoma Antigen Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030116</emdnCode>
    <emdnDescription>SQUAMOUS CELL CARCINOMA ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G216A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:54.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802448</udiDi>
    <basicUdiDi>B-06952804802448</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Carcinoembryonic Antigen Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G207A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:48.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802431</udiDi>
    <basicUdiDi>B-06952804802431</basicUdiDi>
    <tradeName>Ketamine (KET) Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Ketamine (KET) Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160502</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G302A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:46.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802424</udiDi>
    <basicUdiDi>B-06952804802424</basicUdiDi>
    <tradeName>Methamphetamine (MET) Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Methamphetamine (MET) Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160502</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G301A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:45.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802417</udiDi>
    <basicUdiDi>B-06952804802417</basicUdiDi>
    <tradeName>Morphine (MOR) Chemiluminescence Immunoassay  Test Kit</tradeName>
    <deviceName>Morphine (MOR) Chemiluminescence Immunoassay  Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090112</emdnCode>
    <emdnDescription>MORPHINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G300A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:44.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802400</udiDi>
    <basicUdiDi>B-06952804802400</basicUdiDi>
    <tradeName>Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Growth Stimulation Expressed Gene 2 Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021314</emdnCode>
    <emdnDescription>ST2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G022A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:38.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802394</udiDi>
    <basicUdiDi>B-06952804802394</basicUdiDi>
    <tradeName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Lipoprotein-associated Phospholipase A2 Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021312</emdnCode>
    <emdnDescription>LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE A2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G107A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:37.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802387</udiDi>
    <basicUdiDi>B-06952804802387</basicUdiDi>
    <tradeName>Folate Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Folate Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G702A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:36.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802370</udiDi>
    <basicUdiDi>B-06952804802370</basicUdiDi>
    <tradeName>Gastrin-17 Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Gastrin-17 Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G210A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:35.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804802363</udiDi>
    <basicUdiDi>B-06952804802363</basicUdiDi>
    <tradeName>Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit</tradeName>
    <deviceName>Alpha Fetoprotein Chemiluminescence Immunoassay Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G200A08</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:28.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804800697</udiDi>
    <basicUdiDi>B-06952804800697</basicUdiDi>
    <tradeName>06952804800697</tradeName>
    <deviceName>Adenovirus Respiratory Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:27.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804800680</udiDi>
    <basicUdiDi>69528048A4993004H</basicUdiDi>
    <tradeName>Rotavirus Antigen Rapid Test</tradeName>
    <deviceName>Rotavirus Antigen Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A49930</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:26.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804800550</udiDi>
    <basicUdiDi>B-06952804800550</basicUdiDi>
    <tradeName>06952804800550</tradeName>
    <deviceName>LH Ovulation Rapid Tests</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:22:25.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CEA-W23NJ</udiDi>
    <basicUdiDi>B-CEA-W23NJ</basicUdiDi>
    <tradeName>D-CEA-W23NJ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CEA-W23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:10.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CHA-W23PR</udiDi>
    <basicUdiDi>B-CHA-W23PR</basicUdiDi>
    <tradeName>D-CHA-W23PR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHA-W23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:08.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CHKV-W23MC</udiDi>
    <basicUdiDi>B-CHKV-W23MC</basicUdiDi>
    <tradeName>D-CHKV-W23MC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CHKV-W23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:11:08.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMC-W23FBK</udiDi>
    <basicUdiDi>B-CMC-W23FBK</basicUdiDi>
    <tradeName>D-CMC-W23FBK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMC-W23F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:09:57.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMC-W23SG</udiDi>
    <basicUdiDi>B-CMC-W23SG</basicUdiDi>
    <tradeName>D-CMC-W23SG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMC-W23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:09:57.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMLMLS-101GD</udiDi>
    <basicUdiDi>B-CMLMLS-101GD</basicUdiDi>
    <tradeName>D-CMLMLS-101GD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Meter: CML-101 Device: MLS-101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:09:57.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Crypto-F238W</udiDi>
    <basicUdiDi>B-Crypto-F238W</basicUdiDi>
    <tradeName>D-Crypto-F238W</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Crypto-F23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:06:39.278Z</lastUpdated>
  </row>
</eudamedExport>