<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800142100659</udiDi>
    <basicUdiDi>B-08800142100659</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:10.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100642</udiDi>
    <basicUdiDi>B-08800142100642</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:10.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100635</udiDi>
    <basicUdiDi>B-08800142100635</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:09.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100628</udiDi>
    <basicUdiDi>B-08800142100628</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:08.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100611</udiDi>
    <basicUdiDi>B-08800142100611</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:03.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100604</udiDi>
    <basicUdiDi>B-08800142100604</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:02.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100215</udiDi>
    <basicUdiDi>B-08800142100215</basicUdiDi>
    <tradeName>TERA HARZ CLEAR</tradeName>
    <deviceName>TERA HARZ CLEAR</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:02.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100208</udiDi>
    <basicUdiDi>B-08800142100208</basicUdiDi>
    <tradeName>TERA HARZ CLEAR</tradeName>
    <deviceName>TERA HARZ CLEAR</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:01.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100192</udiDi>
    <basicUdiDi>B-08800142100192</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:57.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100185</udiDi>
    <basicUdiDi>B-08800142100185</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:57.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100123</udiDi>
    <basicUdiDi>B-08800142100123</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:54.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800141400118</udiDi>
    <basicUdiDi>B-08800141400118</basicUdiDi>
    <tradeName>Physiotherapy Apparatus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BojongMC Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026761</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120602</emdnCode>
    <emdnDescription>PHYSIOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF-UM-SE</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:54.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800141400019</udiDi>
    <basicUdiDi>B-08800141400019</basicUdiDi>
    <tradeName>Physiotherapy Apparatus</tradeName>
    <deviceName>SP-Series</deviceName>
    <manufacturerName>BojongMC Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026761</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120602</emdnCode>
    <emdnDescription>PHYSIOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TF-UM-SP1100</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:50.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800131300008</udiDi>
    <basicUdiDi>B-08800131300008</basicUdiDi>
    <tradeName>CAI Monitoring System</tradeName>
    <deviceName>Depth of Anesthesia Monitoring System</deviceName>
    <manufacturerName>BrainU Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000033438</manufacturerSrn>
    <authorisedRepresentativeName>Meridius Medical Europe Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004258</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0399</emdnCode>
    <emdnDescription>MEASUREMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFU-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:49.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800130400105</udiDi>
    <basicUdiDi>B-08800130400105</basicUdiDi>
    <tradeName>08800130400105</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEUROPHET, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000019879</manufacturerSrn>
    <authorisedRepresentativeName>KTR Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V92</emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN_NEUROPHET AQUA V1.0</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:48.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800127100056</udiDi>
    <basicUdiDi>B-08800127100056</basicUdiDi>
    <tradeName>08800127100056</tradeName>
    <deviceName>Handpieces</deviceName>
    <manufacturerName>JSKBiomed Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000040867</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0799</emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJHP-M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:47.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800127100049</udiDi>
    <basicUdiDi>B-08800127100049</basicUdiDi>
    <tradeName>08800127100049</tradeName>
    <deviceName>Handpieces</deviceName>
    <manufacturerName>JSKBiomed Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000040867</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0799</emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJHP-F</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:43.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800127100032</udiDi>
    <basicUdiDi>B-08800127100032</basicUdiDi>
    <tradeName>08800127100032</tradeName>
    <deviceName>Handpieces</deviceName>
    <manufacturerName>JSKBiomed Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000040867</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0799</emdnCode>
    <emdnDescription>ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJHP</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:42.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800127100025</udiDi>
    <basicUdiDi>B-08800127100025</basicUdiDi>
    <tradeName>Mirajet nozzle</tradeName>
    <deviceName>Sterile, single use needle free injector</deviceName>
    <manufacturerName>JSKBiomed Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000040867</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010499</emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJNZ-1H250</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:42.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800127100018</udiDi>
    <basicUdiDi>B-08800127100018</basicUdiDi>
    <tradeName>Mirajet nozzle</tradeName>
    <deviceName>Sterile, single use needle free injector</deviceName>
    <manufacturerName>JSKBiomed Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000040867</manufacturerSrn>
    <authorisedRepresentativeName>JaviTech e.K.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005875</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A02010499</emdnCode>
    <emdnDescription>SYRINGES FOR INJECTOR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MJNZ-1H200</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:54:41.373Z</lastUpdated>
  </row>
</eudamedExport>