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<eudamedExport entity="devices">
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    <udiDi>06933265500005</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, XS size</tradeName>
    <deviceName>Disposable Nitrile Examination Gloves, Powder Free</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>MDR 2017/745</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>942011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:53:34.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512299</udiDi>
    <basicUdiDi>69332655EM011235177T7</basicUdiDi>
    <tradeName>06933265512299</tradeName>
    <deviceName>Disposable Medical Face Mask</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>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11030700129</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:53:31.655Z</lastUpdated>
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  <row>
    <udiDi>06933265562546</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>iiSi</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>Disposable nitrile glove, pink color, size XL</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:25.766Z</lastUpdated>
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  <row>
    <udiDi>06933265562539</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>iiSi</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>Disposable nitrile glove, pink color, size L</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:25.066Z</lastUpdated>
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  <row>
    <udiDi>06933265562522</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>iiSi</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>Disposable nitrile glove, pink color, size M</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:25.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265562515</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>iiSi</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>Disposable nitrile glove, pink color, size S</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:20.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265562232</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>ECO</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>BLUE NITRILE XL</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:19.822Z</lastUpdated>
  </row>
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    <udiDi>06933265562225</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>ECO</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>BLUE NITRILE L</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:19.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265562218</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>ECO</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>BLUE NITRILE M</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:17.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265562201</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>ECO</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>BLUE NITRILE-S</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:16.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265562195</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>ECO</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>BLUE NITRILE</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:13.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561778</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>02.1513200LB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:12.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561761</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>02.1513200MB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:12.708Z</lastUpdated>
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  <row>
    <udiDi>06933265561754</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>02.1513200SB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:08.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561747</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>02.1513200XSB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:04:06.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561228</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>PIZZI NITRILE EXAMINATION GLOVES POWDER-FREE, XL</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>92318</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:30.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561211</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>PIZZI NITRILE EXAMINATION GLOVES POWDER-FREE, L</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>92317</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:29.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561204</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>PIZZI NITRILE EXAMINATION GLOVES POWDER-FREE, M</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>92316</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:28.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561198</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>PIZZI NITRILE EXAMINATION GLOVES POWDER-FREE, S</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>92315</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:26.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265561181</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>PIZZI NITRILE EXAMINATION GLOVES POWDER-FREE, XS</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>92314</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:25.100Z</lastUpdated>
  </row>
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