<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09551012401053</udiDi>
    <basicUdiDi>955101240MODEL27P</basicUdiDi>
    <tradeName>IneoGuard</tradeName>
    <deviceName>Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free</deviceName>
    <manufacturerName>Ineo Tech Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000026701</manufacturerSrn>
    <authorisedRepresentativeName>Advanced Barrier Solutions SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000025223</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IG255</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:17:10.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551012400971</udiDi>
    <basicUdiDi>955101240MODEL17M</basicUdiDi>
    <tradeName>IneoGuard</tradeName>
    <deviceName>Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free</deviceName>
    <manufacturerName>Ineo Tech Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000026701</manufacturerSrn>
    <authorisedRepresentativeName>Advanced Barrier Solutions SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000025223</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IG155</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:17:08.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551005941610</udiDi>
    <basicUdiDi>955100594160DK</basicUdiDi>
    <tradeName>Ulma PI Evolution</tradeName>
    <deviceName>Sterile Polyisoprene Surgical Powder Free Gloves</deviceName>
    <manufacturerName>SENTIENX SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000023461</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UPE-100594161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:48.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>09001570557797</udiDi>
    <basicUdiDi>9001570PFM-116SC-S-64V</basicUdiDi>
    <tradeName>sempermed syntegra preCision</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HARPS Investment Asia Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000001645</manufacturerSrn>
    <authorisedRepresentativeName>HARPS Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000040870</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000016672</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:26.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302025</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName>Powder Free Polyisoprene Sterile Surgical Gloves</deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 6 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:06.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977355090069</udiDi>
    <basicUdiDi>697735509H0601CY</basicUdiDi>
    <tradeName>06977355090069</tradeName>
    <deviceName>gloves</deviceName>
    <manufacturerName>Xiantao Hank Protective Products Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042210</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDR</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:29:19.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>26971384152037</udiDi>
    <basicUdiDi>697138415CPI20004NF</basicUdiDi>
    <tradeName>Sterile Surgical gloves 7621</tradeName>
    <deviceName>Sterile Surgical gloves</deviceName>
    <manufacturerName>MOTEX HEALTHCARE (ANHUI) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000014097</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:01:32.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>15414566822556</udiDi>
    <basicUdiDi>5414566GPIPLGIG340088V</basicUdiDi>
    <tradeName>Gammex PI Plus Glove-in-Glove System</tradeName>
    <deviceName>Polyisoprene Surgical Gloves</deviceName>
    <manufacturerName>Ansell Healthcare Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340082055 5.5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:59:29.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>15414566570556</udiDi>
    <basicUdiDi>5414566GNLPIMIC3402063S</basicUdiDi>
    <tradeName>Gammex Non-Latex PI Micro</tradeName>
    <deviceName>Polyisoprene Surgical Gloves</deviceName>
    <manufacturerName>Ansell Healthcare Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340057055 5.5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:59:27.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>15414566560557</udiDi>
    <basicUdiDi>5414566GNLPI340020687G</basicUdiDi>
    <tradeName>Gammex Non-Latex PI</tradeName>
    <deviceName>Polyisoprene Surgical Gloves</deviceName>
    <manufacturerName>Ansell Healthcare Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340056055 5.5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:59:23.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>15414566540559</udiDi>
    <basicUdiDi>5414566GNLPITXT206340SF</basicUdiDi>
    <tradeName>GAMMEX Non-Latex PI Textured</tradeName>
    <deviceName>Polyisoprene Surgical Gloves</deviceName>
    <manufacturerName>Ansell Healthcare Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340054055 Size 5.5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:59:22.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>15414566140551</udiDi>
    <basicUdiDi>5414566GENLPIUG3402063E</basicUdiDi>
    <tradeName>ENCORE Non-Latex PI Underglove</tradeName>
    <deviceName>Polyisoprene Surgical Gloves</deviceName>
    <manufacturerName>Ansell Healthcare Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>330114055 Size 5.5</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:59:10.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884792386517</udiDi>
    <basicUdiDi>5414566GNLPIORT20686NG</basicUdiDi>
    <tradeName>GAMMEX Non-Latex PI Ortho</tradeName>
    <deviceName>Polyisoprene Surgical Gloves</deviceName>
    <manufacturerName>Ansell Healthcare Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>20686560 Size 6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:44.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884792385206</udiDi>
    <basicUdiDi>5414566GNLPIGRN20685F8</basicUdiDi>
    <tradeName>GAMMEX Non-Latex PI Green</tradeName>
    <deviceName>Polyisoprene Surgical Gloves</deviceName>
    <manufacturerName>Ansell Healthcare Europe NV</manufacturerName>
    <manufacturerSrn>BE-MF-000000691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>20685255 Size 5.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T00:52:43.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302056</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 6.5 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:46.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302087</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 7.0 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:45.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302117</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 7.5 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:45.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302148</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 8.0 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:45.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302179</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 8.5 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:45.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302209</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 9.0 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:45.927Z</lastUpdated>
  </row>
</eudamedExport>