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<eudamedExport entity="devices">
  <row>
    <udiDi>18800029902533</udiDi>
    <basicUdiDi>88000299GTUTL20WB</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-4000 / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:48.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902502</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029902502</tradeName>
    <deviceName>ENT Endoscopy Visual System</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENT Endoscopy Visual System / MGSI-CA-260SLCB</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:47.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902496</udiDi>
    <basicUdiDi>88000299GTCA10GQ</basicUdiDi>
    <tradeName>ENT Chair</tradeName>
    <deviceName>ENT Chair</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-1500D / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:45.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902489</udiDi>
    <basicUdiDi>88000299GTUTM20WG</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-600A / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:44.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902472</udiDi>
    <basicUdiDi>88000299GTUT20PQ</basicUdiDi>
    <tradeName>ENT UNIT</tradeName>
    <deviceName>ENT UNIT</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NET-1100 / MGSI-CA-ENT UNIT</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:43.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029901826</udiDi>
    <basicUdiDi>88000299SNSS11RW</basicUdiDi>
    <tradeName>NAVILLOON-E</tradeName>
    <deviceName>Sterile Single-use Balloon Catheter for Eustachian tube Dilatation</deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030308</emdnCode>
    <emdnDescription>ENT SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Navilloon-e / Catalog ver. 2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:20:42.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902519</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029902519</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-02T21:34:49.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029902526</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029902526</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-02T21:34:49.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029903257</udiDi>
    <basicUdiDi>88000299GTVS10PP</basicUdiDi>
    <tradeName>18800029903257</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-02T21:34:49.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>18800029901833</udiDi>
    <basicUdiDi>88000299SNSS11RW</basicUdiDi>
    <tradeName>NAVILLOON-E</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mega Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008718</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030308</emdnCode>
    <emdnDescription>ENT SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-31T07:04:13.499Z</lastUpdated>
  </row>
</eudamedExport>