<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06902139344106</udiDi>
    <basicUdiDi>B-06902139344106</basicUdiDi>
    <tradeName>06902139344106</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, right</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135422016S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:33.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139344090</udiDi>
    <basicUdiDi>B-06902139344090</basicUdiDi>
    <tradeName>06902139344090</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, right</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135422015S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:30.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139344083</udiDi>
    <basicUdiDi>B-06902139344083</basicUdiDi>
    <tradeName>06902139344083</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, right</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135422014S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:29.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139344076</udiDi>
    <basicUdiDi>B-06902139344076</basicUdiDi>
    <tradeName>06902139344076</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, right</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135422013S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:28.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139344069</udiDi>
    <basicUdiDi>B-06902139344069</basicUdiDi>
    <tradeName>06902139344069</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, right</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135422012S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:26.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139344052</udiDi>
    <basicUdiDi>B-06902139344052</basicUdiDi>
    <tradeName>06902139344052</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, right</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135422011S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:23.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343628</udiDi>
    <basicUdiDi>B-06902139343628</basicUdiDi>
    <tradeName>06902139343628</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, right</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135422010S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:21.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343611</udiDi>
    <basicUdiDi>B-06902139343611</basicUdiDi>
    <tradeName>06902139343611</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421017S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:21.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343604</udiDi>
    <basicUdiDi>B-06902139343604</basicUdiDi>
    <tradeName>06902139343604</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421016S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:19.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343598</udiDi>
    <basicUdiDi>B-06902139343598</basicUdiDi>
    <tradeName>06902139343598</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421015S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:17.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343581</udiDi>
    <basicUdiDi>B-06902139343581</basicUdiDi>
    <tradeName>06902139343581</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421014S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:15.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343574</udiDi>
    <basicUdiDi>B-06902139343574</basicUdiDi>
    <tradeName>06902139343574</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421013S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:14.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343567</udiDi>
    <basicUdiDi>B-06902139343567</basicUdiDi>
    <tradeName>06902139343567</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421012S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:13.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343550</udiDi>
    <basicUdiDi>B-06902139343550</basicUdiDi>
    <tradeName>06902139343550</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421011S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:10.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139343543</udiDi>
    <basicUdiDi>B-06902139343543</basicUdiDi>
    <tradeName>06902139343543</tradeName>
    <deviceName>Femoral Cruciate Substituting, Cemented, left</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0909030101</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135421010S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:35:09.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999539856477</udiDi>
    <basicUdiDi>B-05999539856477</basicUdiDi>
    <tradeName>TB-I 6-14 PS Teljes térdízületi protézis tibia inzert PS-típus</tradeName>
    <deviceName>Total knee joint prosthesis - tibial insert</deviceName>
    <manufacturerName>Metrimed Orvosi Műszergyártó Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004640</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P090903020202</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-I 6-14 PS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:12:03.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999539856460</udiDi>
    <basicUdiDi>B-05999539856460</basicUdiDi>
    <tradeName>TB-I 6-12 PS Teljes térdízületi protézis tibia inzert PS-típus</tradeName>
    <deviceName>Total knee joint prosthesis - tibial insert</deviceName>
    <manufacturerName>Metrimed Orvosi Műszergyártó Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004640</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P090903020202</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-I 6-12 PS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:12:03.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999539856453</udiDi>
    <basicUdiDi>B-05999539856453</basicUdiDi>
    <tradeName>TB-I 6-10 PS Teljes térdízületi protézis tibia inzert PS-típus</tradeName>
    <deviceName>Total knee joint prosthesis - tibial insert</deviceName>
    <manufacturerName>Metrimed Orvosi Műszergyártó Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004640</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P090903020202</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-I 6-10 PS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:11:47.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999539856446</udiDi>
    <basicUdiDi>B-05999539856446</basicUdiDi>
    <tradeName>TB-I 5-20 PS Teljes térdízületi protézis tibia inzert PS-típus</tradeName>
    <deviceName>Total knee joint prosthesis - tibial insert</deviceName>
    <manufacturerName>Metrimed Orvosi Műszergyártó Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004640</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P090903020202</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-I 5-20 PS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:11:47.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>05999539856439</udiDi>
    <basicUdiDi>B-05999539856439</basicUdiDi>
    <tradeName>TB-I 5-17 PS Teljes térdízületi protézis tibia inzert PS-típus</tradeName>
    <deviceName>Total knee joint prosthesis - tibial insert</deviceName>
    <manufacturerName>Metrimed Orvosi Műszergyártó Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004640</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P090903020202</emdnCode>
    <emdnDescription>BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-I 5-17 PS</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:11:46.304Z</lastUpdated>
  </row>
</eudamedExport>