<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>09551028345204</udiDi>
    <basicUdiDi>955102834KOINNRPP50KF</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PPS50N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:15.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345211</udiDi>
    <basicUdiDi>955102834KOINNRPP50KF</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PPS50N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:15.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345228</udiDi>
    <basicUdiDi>955102834KOINNRPP50KF</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PPS50N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:15.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345235</udiDi>
    <basicUdiDi>955102834KOINNRPP50KF</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PPS50N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:15.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345242</udiDi>
    <basicUdiDi>955102834KOINNRPP50KF</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PPS50N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345266</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345273</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345280</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345297</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:14.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345303</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:00.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345310</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:00.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345327</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:00.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345334</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:00.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551028345341</udiDi>
    <basicUdiDi>955102834KOINNRPF50HV</basicUdiDi>
    <tradeName>KOIN SMH MEDIKAL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qube Medical Products Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000022842</manufacturerSrn>
    <authorisedRepresentativeName>Qube Integrated Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000046698</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR9PFPT50NPC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:47:00.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551004310134</udiDi>
    <basicUdiDi>955760100560GG</basicUdiDi>
    <tradeName>SOFTSKIN POKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP GLOVE SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000009690</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPPFS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:12:47.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551004310141</udiDi>
    <basicUdiDi>955760100560GG</basicUdiDi>
    <tradeName>SOFTSKIN POKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP GLOVE SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000009690</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPPFM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:12:45.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>09551004310158</udiDi>
    <basicUdiDi>955760100560GG</basicUdiDi>
    <tradeName>SOFTSKIN POKA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TOP GLOVE SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000009690</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LPPFL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T06:12:44.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>00806363505462</udiDi>
    <basicUdiDi>806363LEGPKJ</basicUdiDi>
    <tradeName>Naturflex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kanam Latex Industries Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000022741</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128920</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:19:42.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00806363505493</udiDi>
    <basicUdiDi>806363LEGFJW</basicUdiDi>
    <tradeName>Naturflex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kanam Latex Industries Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000022741</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>128915</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:19:42.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>00806363506315</udiDi>
    <basicUdiDi>806363LEGPKJ</basicUdiDi>
    <tradeName>DOC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kanam Latex Industries Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000022741</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOCS K 6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:19:41.458Z</lastUpdated>
  </row>
</eudamedExport>