<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978676491733</udiDi>
    <basicUdiDi>697867649C01W2</basicUdiDi>
    <tradeName>06978676491733</tradeName>
    <deviceName>Coverall (PP coverall, SMS coverall, Microporous coverall.PP+PE coverall)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</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>A601- S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:05.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676491702</udiDi>
    <basicUdiDi>697867649FM01UM</basicUdiDi>
    <tradeName>06978676491702</tradeName>
    <deviceName>Face mask (Nonwoven Face mask, Activated carbon face mask, Anti-dust mask, Cup shaped mask, face mask with plastic shield, Dust mask, Paper face mask,3D face mask)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020699</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FACE MASK Earloop</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:04.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676491405</udiDi>
    <basicUdiDi>697867649G01WN</basicUdiDi>
    <tradeName>06978676491405</tradeName>
    <deviceName>Gloves (Nitrile gloves, Latex gloves, PE gloves, TPE gloves, Vinyl gloves/PVC gloves, Veterinary gloves)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0199</emdnCode>
    <emdnDescription>GLOVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nitrile gloves 8901- S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:00.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676491306</udiDi>
    <basicUdiDi>697867649SC02VY</basicUdiDi>
    <tradeName>06978676491306</tradeName>
    <deviceName>Sleeve Cover (PP sleeve cover, SMS sleeve cover, Microporous sleeve cover, PE sleeve cover, PVC sleeve cover)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</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>PP Sleeve cover 1301- L/XL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:00.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676491283</udiDi>
    <basicUdiDi>697867649BC01S7</basicUdiDi>
    <tradeName>06978676491283</tradeName>
    <deviceName>Beard Cover (Nylon beard net,PP Beard cover)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</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>PP Beard cover 1205 18”</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:44.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676491047</udiDi>
    <basicUdiDi>697867649SC01VW</basicUdiDi>
    <tradeName>06978676491047</tradeName>
    <deviceName>Shoe cover (Non-skid shoe cover, PP shoe cover, PE shoe cover, CPE shoe cover, PP+CPE shoe cover, PP boot cover, PE Boot cover, microporous boot cover)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</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>Non-skid Shoe cover 1805 L</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:44.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676490897</udiDi>
    <basicUdiDi>697867649A01VQ</basicUdiDi>
    <tradeName>06978676490897</tradeName>
    <deviceName>Apron (PE Apron, PP apron, PP+PE apron, PVC Apron，Disposable skirt)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</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>PE Apron 2401- L</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:43.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676490668</udiDi>
    <basicUdiDi>697867649DC01SM</basicUdiDi>
    <tradeName>06978676490668</tradeName>
    <deviceName>Disposable Cap (Bouffant cap/Nurse cap, Doctor Cap, Surgeon cap, Clip cap/Mob cap/Strip cap, Nylon cap/Nylon hairnet, Astronaut Cap/Hood cap, PE Cap, Snood Cap, Peak Cap)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</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>Bouffant cap/Nurse cap 111519-19”</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:42.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676490514</udiDi>
    <basicUdiDi>697867649LC01UD</basicUdiDi>
    <tradeName>06978676490514</tradeName>
    <deviceName>Lab Coat（Visitor gown, PE Visitor coat）</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</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>Lab coat 1711- S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:38.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676490484</udiDi>
    <basicUdiDi>697867649SG01WJ</basicUdiDi>
    <tradeName>06978676490484</tradeName>
    <deviceName>Surgical gown</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A502-S-3XL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:37.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978676490002</udiDi>
    <basicUdiDi>697867649IG01UC</basicUdiDi>
    <tradeName>06978676490002</tradeName>
    <deviceName>Isolation gown (scrub suit, patient gown, CPE gown,PP gown,trousers, nursing pants，shorts)</deviceName>
    <manufacturerName>One Top Protective Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023063</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>Scrub Suit 1708- S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:36.940Z</lastUpdated>
  </row>
</eudamedExport>