<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00697549344582</udiDi>
    <basicUdiDi>697549344APRONSY4</basicUdiDi>
    <tradeName>Apron - PE</tradeName>
    <deviceName>Apron</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0209</emdnCode>
    <emdnDescription>SURGICAL APRONS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Apron - PE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:54.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344513</udiDi>
    <basicUdiDi>697549344PYJAMASEN</basicUdiDi>
    <tradeName>Scrub Suit - SBPP</tradeName>
    <deviceName>Scrub Suit</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Scrub Suit - SBPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:53.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344469</udiDi>
    <basicUdiDi>697549344MATTRESSCOVERSCN</basicUdiDi>
    <tradeName>Mattress Cover - SBPP</tradeName>
    <deviceName>Mattress Cover</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020199</emdnCode>
    <emdnDescription>SURGICAL DRAPES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mattress Cover - SBPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:52.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344384</udiDi>
    <basicUdiDi>697549344COVERALLSBP</basicUdiDi>
    <tradeName>Coverall - PE</tradeName>
    <deviceName>Coverall</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0205</emdnCode>
    <emdnDescription>NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Coverall - PE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:48.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344308</udiDi>
    <basicUdiDi>697549344SURGICALGOWNSUC</basicUdiDi>
    <tradeName>Surgical Gown - SBPP</tradeName>
    <deviceName>Surgical Gown</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Surgical Gown - SBPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:47.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344186</udiDi>
    <basicUdiDi>697549344SHOECOVERS93</basicUdiDi>
    <tradeName>Shoe Cover - HDPE</tradeName>
    <deviceName>Shoe Cover</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0208</emdnCode>
    <emdnDescription>SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Shoe Cover - HDPE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:46.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344148</udiDi>
    <basicUdiDi>697549344ISOLATIONGOWNS6R</basicUdiDi>
    <tradeName>Isolation Gown - SBPP</tradeName>
    <deviceName>Isolation Gown</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0205</emdnCode>
    <emdnDescription>NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Isolation Gown - SBPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:42.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344094</udiDi>
    <basicUdiDi>697549344INSPECTIONGOWN3X</basicUdiDi>
    <tradeName>Lab Coat - SBPP</tradeName>
    <deviceName>Inspection Gown / Lab Coat</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0205</emdnCode>
    <emdnDescription>NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lab Coat - SBPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:41.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344056</udiDi>
    <basicUdiDi>697549344MASKSTT</basicUdiDi>
    <tradeName>Disposable medical face mask- ear-loop</tradeName>
    <deviceName>Disposable medical face mask</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020603</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Disposable medical face mask- ear-loop</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:40.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344001</udiDi>
    <basicUdiDi>697549344CAPSQS</basicUdiDi>
    <tradeName>Mob Cap</tradeName>
    <deviceName>Cap</deviceName>
    <manufacturerName>CARESTONE MEDICAL &amp; PROTECTIVE PRODUCTS CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027756</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0207</emdnCode>
    <emdnDescription>CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mob Cap</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:39.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060660611369</udiDi>
    <basicUdiDi>697460865002/0089RB</basicUdiDi>
    <tradeName>15060660611369</tradeName>
    <deviceName>Dental Bib Holders</deviceName>
    <manufacturerName>WELLMED DENTAL MEDICAL SUPPLY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000003243</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PFT-002/0089</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:36:26.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974523671778</udiDi>
    <basicUdiDi>697452367A009EV</basicUdiDi>
    <tradeName>Reinforced Surgical Gown</tradeName>
    <deviceName>Reinforced Surgical Gown</deviceName>
    <manufacturerName>S.E.S Healthcare products (Lingbi)  Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001143</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>385303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:36:07.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974523671167</udiDi>
    <basicUdiDi>697452367A001ED</basicUdiDi>
    <tradeName>Standard Surgical Gown</tradeName>
    <deviceName>Surgical Gown</deviceName>
    <manufacturerName>S.E.S Healthcare products (Lingbi)  Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001143</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>385203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:36:02.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974436068030</udiDi>
    <basicUdiDi>697443606I00018B</basicUdiDi>
    <tradeName>Standard surgical gown</tradeName>
    <deviceName>Surgical gown</deviceName>
    <manufacturerName>Xiantao Zhongtai Protective Products Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008476</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XXL</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:27.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974436062007</udiDi>
    <basicUdiDi>697443606A00025M</basicUdiDi>
    <tradeName>Type IIR mask with tie</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiantao Zhongtai Protective Products Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008476</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>no</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:26.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974436061079</udiDi>
    <basicUdiDi>697443606C000169</basicUdiDi>
    <tradeName>06974436061079</tradeName>
    <deviceName>Isolation gown</deviceName>
    <manufacturerName>Xiantao Zhongtai Protective Products Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008476</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20g PP, L</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:26.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974424840136</udiDi>
    <basicUdiDi>697442484L05QF</basicUdiDi>
    <tradeName>06974424840136</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leboo Healthcare Products Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000008521</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0207</emdnCode>
    <emdnDescription>CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LVAL-N62C01-GS10BB-B00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:25.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974424840129</udiDi>
    <basicUdiDi>697442484L03QB</basicUdiDi>
    <tradeName>06974424840129</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leboo Healthcare Products Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000008521</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LVAL-N61A03-GS16CL-B00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:21.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974100422397</udiDi>
    <basicUdiDi>69741004231003F</basicUdiDi>
    <tradeName>Cubre Barbas Desechable de Polipropileno</tradeName>
    <deviceName>Disposable Polypropylene Beard Cover</deviceName>
    <manufacturerName>Uhealth Medical (Beijing) Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043700</manufacturerSrn>
    <authorisedRepresentativeName>LUHEPA INTERNACIONAL, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043668</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3100O</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:07.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974100422380</udiDi>
    <basicUdiDi>69741004264004K</basicUdiDi>
    <tradeName>Cubre Zapatos de Polipropileno Desechable</tradeName>
    <deviceName>Disposable Polypropylene Shoe Covers</deviceName>
    <manufacturerName>Uhealth Medical (Beijing) Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043700</manufacturerSrn>
    <authorisedRepresentativeName>LUHEPA INTERNACIONAL, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043668</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0208</emdnCode>
    <emdnDescription>SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6400O</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:35:06.889Z</lastUpdated>
  </row>
</eudamedExport>