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    <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>942029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:24.105Z</lastUpdated>
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    <udiDi>06933265559881</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>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:23.689Z</lastUpdated>
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    <udiDi>06933265559874</udiDi>
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    <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>942027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:23.599Z</lastUpdated>
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    <udiDi>06933265559867</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>942026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:17.341Z</lastUpdated>
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    <udiDi>06933265559850</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, XS 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>942025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:16.163Z</lastUpdated>
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    <udiDi>06933265556927</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Cobalt 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-COB10-XL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:14.948Z</lastUpdated>
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    <udiDi>06933265556910</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Cobalt 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-COB10-L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:13.748Z</lastUpdated>
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    <udiDi>06933265556903</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Cobalt 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-COB10-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:11.351Z</lastUpdated>
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    <udiDi>06933265556897</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Cobalt 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-COB10-S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:10.149Z</lastUpdated>
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    <udiDi>06933265515689</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>GLOVTEC Cobalt 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-COB10-XS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:08.945Z</lastUpdated>
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    <udiDi>06933265513777</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves Powder-free, White, 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>Nitrile EM series-White</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:03:00.520Z</lastUpdated>
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    <udiDi>06933265513760</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves Powder-free White 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>Nitrile EM series-White</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:59.333Z</lastUpdated>
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  <row>
    <udiDi>06933265513753</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves Powder-free White 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>Nitrile EM series-White</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:56.924Z</lastUpdated>
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    <udiDi>06933265513746</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves Powder-free White 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>Nitrile EM series</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:55.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265513739</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves Powder-free White, XS 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>Nitrile EM series</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:54.550Z</lastUpdated>
  </row>
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    <udiDi>06933265512992</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves 4.0g 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>Nitrile EM series</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:52.113Z</lastUpdated>
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    <udiDi>06933265512985</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves 4.0g Powder-free Blue 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>Nitrile EM series</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:49.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512978</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves 4.0g Powder-free Blue 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>Nitrile EM series</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:48.516Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512961</udiDi>
    <basicUdiDi>69332655EM01021562864B</basicUdiDi>
    <tradeName>Disposable Nitrile Examination Gloves 4.0g Powder-free Blue 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>Nitrile EM series</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:47.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>06933265512473</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-XL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:02:46.231Z</lastUpdated>
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