<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08806102620151</udiDi>
    <basicUdiDi>880610260002B9</basicUdiDi>
    <tradeName>KOVAX-NEEDLE</tradeName>
    <deviceName>Sterile Single Use Needles</deviceName>
    <manufacturerName>Korea Vaccine co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000028066</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010199</emdnCode>
    <emdnDescription>HYPODERMIC NEEDLES - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>11-627</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:14.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806102630204</udiDi>
    <basicUdiDi>880610260003BB</basicUdiDi>
    <tradeName>08806102630204</tradeName>
    <deviceName>Sterile Single I.V. Catheters</deviceName>
    <manufacturerName>Korea Vaccine co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000028066</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104020205</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>96-38</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:38:13.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806102610985</udiDi>
    <basicUdiDi>880610260005BF</basicUdiDi>
    <tradeName>KOVAX-FILTERNEEDLE SYRINGE</tradeName>
    <deviceName>Sterile Single-Use Syringes with filter needles</deviceName>
    <manufacturerName>Korea Vaccine co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000028066</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010499</emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>14-1279</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:58.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806102610657</udiDi>
    <basicUdiDi>880610260004BD</basicUdiDi>
    <tradeName>08806102610657</tradeName>
    <deviceName>Sterile Single-Use Syringes without needles</deviceName>
    <manufacturerName>Korea Vaccine co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000028066</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010499</emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>18-4598</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:57.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806102610541</udiDi>
    <basicUdiDi>880610260001B7</basicUdiDi>
    <tradeName>KOVAX-SYRINGE</tradeName>
    <deviceName>Sterile Single-Use Syringes with needles</deviceName>
    <manufacturerName>Korea Vaccine co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000028066</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010499</emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>84-6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:37:55.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800136100009</udiDi>
    <basicUdiDi>88001361MF00023J</basicUdiDi>
    <tradeName>Ceramic Etchant 5</tradeName>
    <deviceName>Ceramic Etchant 5, Ceramic Etchant 9, Zirconia Etchant, Zirconia Etchant Cloud System</deviceName>
    <manufacturerName>MEDIFIVE</manufacturerName>
    <manufacturerSrn>KR-MF-000016709</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010299</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:48.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800067900068</udiDi>
    <basicUdiDi>006790006L9</basicUdiDi>
    <tradeName>RESILION</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEXAR HUMANCARE CO.,LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000018422</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>2022 04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T01:44:07.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800067900075</udiDi>
    <basicUdiDi>006790007LB</basicUdiDi>
    <tradeName>RESILION</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HEXAR HUMANCARE CO.,LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000018422</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>2022 03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T01:44:07.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800136100016</udiDi>
    <basicUdiDi>88001361MF00023J</basicUdiDi>
    <tradeName>Ceramic Etchant 9</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIFIVE</manufacturerName>
    <manufacturerSrn>KR-MF-000016709</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010299</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:05:38.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800136100023</udiDi>
    <basicUdiDi>88001361MF00023J</basicUdiDi>
    <tradeName>Zirconia Etchant</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIFIVE</manufacturerName>
    <manufacturerSrn>KR-MF-000016709</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010299</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:05:38.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800136100030</udiDi>
    <basicUdiDi>88001361MF00023J</basicUdiDi>
    <tradeName>Zirconia Etchant Cloud System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MEDIFIVE</manufacturerName>
    <manufacturerSrn>KR-MF-000016709</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010299</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T20:05:38.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800046921329</udiDi>
    <basicUdiDi>B-08800046921329</basicUdiDi>
    <tradeName>LUXEN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DENTALMAX Co., LTD</manufacturerName>
    <manufacturerSrn>KR-MF-000014617</manufacturerSrn>
    <authorisedRepresentativeName>Certification Experts</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000235</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Luxen Zr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T16:51:55.828Z</lastUpdated>
  </row>
</eudamedExport>