<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719883750280</udiDi>
    <basicUdiDi>471988375BleaheatlampBH</basicUdiDi>
    <tradeName>BT Cool Easy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750280</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750303</udiDi>
    <basicUdiDi>B-04719883750303</basicUdiDi>
    <tradeName>APOZA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OZONE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750334</udiDi>
    <basicUdiDi>B-04719883750334</basicUdiDi>
    <tradeName>APOZA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OZONE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750334</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750341</udiDi>
    <basicUdiDi>B-04719883750341</basicUdiDi>
    <tradeName>APOZA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OZONE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750341</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750495</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>D2000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750495</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750501</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>E-MorLit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750525</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>E-MorLit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750525</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750532</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>D2000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750532</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750563</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>E-MorLit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750563</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750617</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>LED 10W</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750617</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750815</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>TOP LIGHT TURBO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750815</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883750860</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>TOP 5W</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883750860</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:26.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883751089</udiDi>
    <basicUdiDi>471988375CuringLight7D</basicUdiDi>
    <tradeName>D2000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APOZA ENTERPRISE CO., LTD.</manufacturerName>
    <manufacturerSrn>TW-MF-000033094</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>COLD LIGHT DENTAL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04719883751089</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-21T18:54:25.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260236850800</udiDi>
    <basicUdiDi>B-04260236850800</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-350031 / 3K-01-350151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260236850817</udiDi>
    <basicUdiDi>B-04260236850817</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-350031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260236850961</udiDi>
    <basicUdiDi>B-04260236850961</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-350033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260236850978</udiDi>
    <basicUdiDi>B-04260236850978</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3S-01-350035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260236851081</udiDi>
    <basicUdiDi>B-04260236851081</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Test Strip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3S-01-350036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260236851104</udiDi>
    <basicUdiDi>B-04260236851104</basicUdiDi>
    <tradeName>FIABiomed Precisa Blood Glucose Monitoring System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HMD Biomedical Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000032809</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3K-01-350034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T10:44:49.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719879265163</udiDi>
    <basicUdiDi>471987926OceanLEDNK</basicUdiDi>
    <tradeName>OceanLED i6MB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Mediland Enterprise Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000012153</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12010701</emdnCode>
    <emdnDescription>FIXED SCIALYTIC LAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OceanLED i6MB</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-18T14:44:30.627Z</lastUpdated>
  </row>
</eudamedExport>