<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05037331020440</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Hypa Touch Examination Nitrile Gloves Nitrile Gloves (Blue)</tradeName>
    <deviceName>Disposable Nitrile Examination Gloves, Powder Free</deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q2683PR x 6 units</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:52:30.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>05430000726399</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Detectaplast Nitril blue gloves,2 pcs in a zipper bag,size large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9131</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:26.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060924462105</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>JFA Nitrile Gloves - Blue, Large - Insert for FAK</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JF1185</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:11.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975443350002</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves,Powder-free, Blue, XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nitrile EM series_XS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:45.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975443350019</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves,  Powder-free, Blue, S size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nitrile EM series_S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:45.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975443350026</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves,  Powder-free, Blue, M size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nitrile EM series_M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:44.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975443350033</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves,  Powder-free, Blue, L size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nitrile EM series_L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:44.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975443350040</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves, , Powder-free, Blue, XL size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nitrile EM series_XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:44.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975443350057</udiDi>
    <basicUdiDi>697544335EM0102156286L4</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves, Powder-free, Blue, XXL size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Blue Sail Health Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000020659</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nitrile EM series_XXL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:44.934Z</lastUpdated>
  </row>
</eudamedExport>