<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08699412005462</udiDi>
    <basicUdiDi>B-08699412005462</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>INFLATABLE MASK NO 6</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130 216</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:06:36.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698573038111</udiDi>
    <basicUdiDi>B-08698573038111</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>INFLATABLE MASK NO 1</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130 211</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:41:31.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698573038104</udiDi>
    <basicUdiDi>B-08698573038104</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>INFLATABLE MASK NO 0</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130 210</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:41:24.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013378</udiDi>
    <basicUdiDi>697350401DAM0396</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2001NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:19.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013385</udiDi>
    <basicUdiDi>697350401DAM0396</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2002NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:19.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013392</udiDi>
    <basicUdiDi>697350401DAM0396</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2003NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:19.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013408</udiDi>
    <basicUdiDi>697350401DAM0396</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2004NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:19.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013415</udiDi>
    <basicUdiDi>697350401DAM0396</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2005NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:19.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013422</udiDi>
    <basicUdiDi>697350401DAM0396</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2006NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:19.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013446</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2101NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013453</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2102NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013460</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2103NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013477</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2104NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013484</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2105NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013491</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2106NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013507</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2107NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973504013514</udiDi>
    <basicUdiDi>697350401DAM0498</basicUdiDi>
    <tradeName>Disposable Anesthetic Masks</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ningbo Huakun Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008459</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2108NS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:52:17.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707480159956</udiDi>
    <basicUdiDi>570748030100901008L</basicUdiDi>
    <tradeName>Ambu® King Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1032UB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:51:08.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707480160303</udiDi>
    <basicUdiDi>570748030100901008L</basicUdiDi>
    <tradeName>Ambu® King Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1145SH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:51:04.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>05707480160280</udiDi>
    <basicUdiDi>570748030100901008L</basicUdiDi>
    <tradeName>Ambu® King Mask</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ambu A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000001437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010101</emdnCode>
    <emdnDescription>ANAESTHETIC FACE MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1145SB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:50:52.800Z</lastUpdated>
  </row>
</eudamedExport>