<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800115200218</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName>OK-Strips, OK-Proxofile</deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS1560/4</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:33:00.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200010</udiDi>
    <basicUdiDi>88001152H-0001PL</basicUdiDi>
    <tradeName>OK-Handpiece</tradeName>
    <deviceName>Low Speed Dental Handpiece, pneumatic</deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12110199</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKH4</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:59.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200331</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:50:25.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201406</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:50:25.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201444</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T22:50:25.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200225</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS1560H/4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200232</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS1580/4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200317</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS25H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200348</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS40H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200362</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Proxofile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKSP40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200379</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200386</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS60H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200409</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS80</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115200416</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS80H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201147</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS15SR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201154</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS25SR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201161</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS40SR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201192</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Proxofile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKP1540/2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201208</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Proxofile</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKP1540/4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800115201215</udiDi>
    <basicUdiDi>88001152S-0001U3</basicUdiDi>
    <tradeName>OK-Strips</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaintek Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000045113</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKS25H/2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T17:04:43.303Z</lastUpdated>
  </row>
</eudamedExport>