<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03665318015312</udiDi>
    <basicUdiDi>697460865CP4-007FX</basicUdiDi>
    <tradeName>MASQUES IIR CLINIX</tradeName>
    <deviceName>Face Masks</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>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3145852</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:39:07.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>03665318011468</udiDi>
    <basicUdiDi>697460865CP4-011-10ZD</basicUdiDi>
    <tradeName>MASQUES IIR CLINIX</tradeName>
    <deviceName>Face Masks</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>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3140899</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:39:06.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>03665318011451</udiDi>
    <basicUdiDi>697460865CP4-002-10Z9</basicUdiDi>
    <tradeName>MASQUES IIR CLINIX</tradeName>
    <deviceName>Face Masks</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>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3140898</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:39:06.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>03665318011420</udiDi>
    <basicUdiDi>697460865CP4-010FL</basicUdiDi>
    <tradeName>MASQUES IIR CLINIX</tradeName>
    <deviceName>Face Masks</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>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3140902</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:39:05.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344728</udiDi>
    <basicUdiDi>697549344PEPANTSAJ</basicUdiDi>
    <tradeName>Sauna Pants - PE</tradeName>
    <deviceName>Sauna Pants</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>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sauna Pants - PE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:39:01.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344698</udiDi>
    <basicUdiDi>697549344ENDOTRAYHOOD67</basicUdiDi>
    <tradeName>Hood Set for Endoscope Trays - Type 1</tradeName>
    <deviceName>Hood Set for Endoscope Trays</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>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hood Set for Endoscope Trays - Type 1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:39:00.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344667</udiDi>
    <basicUdiDi>697549344PEHOODS9H</basicUdiDi>
    <tradeName>PE Hood - S</tradeName>
    <deviceName>PE Hood</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>T030599</emdnCode>
    <emdnDescription>HEALTH SERVICE PREMISES PROTECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE Hood - S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:59.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>00697549344643</udiDi>
    <basicUdiDi>697549344BEARDCOVERSD5</basicUdiDi>
    <tradeName>Beard Cover - SBPP</tradeName>
    <deviceName>Beard 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>T030101</emdnCode>
    <emdnDescription>COVER CAPS, INSTRUMENTS AND EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Beard Cover - SBPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:58.867Z</lastUpdated>
  </row>
  <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>00697549344551</udiDi>
    <basicUdiDi>697549344PEGLOVESR5</basicUdiDi>
    <tradeName>PE Glove - S</tradeName>
    <deviceName>PE Glove</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>T01020202</emdnCode>
    <emdnDescription>POLYETHYLENE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE Glove - S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:54.051Z</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>00697549344254</udiDi>
    <basicUdiDi>697549344SLEEVECOVERS8J</basicUdiDi>
    <tradeName>Sleeve Cover - PE</tradeName>
    <deviceName>Sleeve 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>T030599</emdnCode>
    <emdnDescription>HEALTH SERVICE PREMISES PROTECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sleeve Cover - PE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:38:46.851Z</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>
</eudamedExport>