<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06933265512466</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>nit-BS-GLO-BLU10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:42.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512459</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>nit-BS-GLO-BLU10-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:41.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512442</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>nit-BS-GLO-BLU10-S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:40.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512435</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Blue</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>nit-BS-GLO-BLU10-XS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:38.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512305</udiDi>
    <basicUdiDi>69332655EM011235177T7</basicUdiDi>
    <tradeName>06933265512305</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0112-EM</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:37.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500630</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Farmadosis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>02.1513100XLB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:17.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500623</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Farmadosis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>02.1513100LB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:16.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500616</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Farmadosis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>02.1513100MB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:12.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500609</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Farmadosis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>02.1513100SB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:11.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500593</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Farmadosis</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>02.1513100XSB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:10.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500074</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, XL size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>942015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:08.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500067</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, L size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>942014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:05.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500050</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, M size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>942013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:04.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265500029</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, S size</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>942012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:01.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975443350170</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>JFA brand Disposable Nitrile Glove,Blue Colour,Finger Textured,Non Sterile,Size L,1Pair/Bag</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sail Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001139</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>JF1185</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:30:44.915Z</lastUpdated>
  </row>
</eudamedExport>