<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06902139329585</udiDi>
    <basicUdiDi>B-06902139329585</basicUdiDi>
    <tradeName>06902139329585</tradeName>
    <deviceName>TBG Cementless Hip Stem, HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130600006S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:13.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329578</udiDi>
    <basicUdiDi>B-06902139329578</basicUdiDi>
    <tradeName>06902139329578</tradeName>
    <deviceName>TBG Cementless Hip Stem, HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130590005S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:12.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329561</udiDi>
    <basicUdiDi>B-06902139329561</basicUdiDi>
    <tradeName>06902139329561</tradeName>
    <deviceName>TBG Cementless Hip Stem, HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130580004S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:08.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329554</udiDi>
    <basicUdiDi>B-06902139329554</basicUdiDi>
    <tradeName>06902139329554</tradeName>
    <deviceName>TBG Cementless Hip Stem, HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130570003S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:08.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329547</udiDi>
    <basicUdiDi>B-06902139329547</basicUdiDi>
    <tradeName>06902139329547</tradeName>
    <deviceName>TBG Cementless Hip Stem, HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130560002S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:07.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329448</udiDi>
    <basicUdiDi>B-06902139329448</basicUdiDi>
    <tradeName>06902139329448</tradeName>
    <deviceName>TBG Cementless Hip Stem, Ti-HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130530008S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:06.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329431</udiDi>
    <basicUdiDi>B-06902139329431</basicUdiDi>
    <tradeName>06902139329431</tradeName>
    <deviceName>TBG Cementless Hip Stem, Ti-HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130520007S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:02.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329424</udiDi>
    <basicUdiDi>B-06902139329424</basicUdiDi>
    <tradeName>06902139329424</tradeName>
    <deviceName>TBG Cementless Hip Stem, Ti-HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130510006S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:01.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329417</udiDi>
    <basicUdiDi>B-06902139329417</basicUdiDi>
    <tradeName>06902139329417</tradeName>
    <deviceName>TBG Cementless Hip Stem, Ti-HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130500005S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:00.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329400</udiDi>
    <basicUdiDi>B-06902139329400</basicUdiDi>
    <tradeName>06902139329400</tradeName>
    <deviceName>TBG Cementless Hip Stem, Ti-HA coating</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>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130490004S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:34:00.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329394</udiDi>
    <basicUdiDi>B-06902139329394</basicUdiDi>
    <tradeName>06902139329394</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130480003S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:32:06.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329387</udiDi>
    <basicUdiDi>B-06902139329387</basicUdiDi>
    <tradeName>06902139329387</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>P090804010202</emdnCode>
    <emdnDescription>UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130470002S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:32:05.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329356</udiDi>
    <basicUdiDi>B-06902139329356</basicUdiDi>
    <tradeName>06902139329356</tradeName>
    <deviceName>Ceramic Femoral Head</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>P090804050201</emdnCode>
    <emdnDescription>CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130653602S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:32:04.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329370</udiDi>
    <basicUdiDi>B-06902139329370</basicUdiDi>
    <tradeName>06902139329370</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>P090804050201</emdnCode>
    <emdnDescription>CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130653604S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:32:04.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329349</udiDi>
    <basicUdiDi>B-06902139329349</basicUdiDi>
    <tradeName>06902139329349</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>P090804050201</emdnCode>
    <emdnDescription>CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130653601S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:31:52.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329332</udiDi>
    <basicUdiDi>B-06902139329332</basicUdiDi>
    <tradeName>06902139329332</tradeName>
    <deviceName>Ceramic Femoral Head</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>P090804050201</emdnCode>
    <emdnDescription>CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130643203S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:31:49.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329325</udiDi>
    <basicUdiDi>B-06902139329325</basicUdiDi>
    <tradeName>06902139329325</tradeName>
    <deviceName>Ceramic Femoral Head</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>P090804050201</emdnCode>
    <emdnDescription>CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130643202S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:31:48.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329318</udiDi>
    <basicUdiDi>B-06902139329318</basicUdiDi>
    <tradeName>06902139329318</tradeName>
    <deviceName>Ceramic Femoral Head</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>P090804050201</emdnCode>
    <emdnDescription>CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130643201S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:31:47.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329301</udiDi>
    <basicUdiDi>B-06902139329301</basicUdiDi>
    <tradeName>06902139329301</tradeName>
    <deviceName>Ceramic Femoral Head</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>P090804050201</emdnCode>
    <emdnDescription>CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130632803S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:31:45.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139329295</udiDi>
    <basicUdiDi>B-06902139329295</basicUdiDi>
    <tradeName>06902139329295</tradeName>
    <deviceName>Ceramic Acetabular Liner</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>P0908030402</emdnCode>
    <emdnDescription>HIP PROSTHESES CERAMIC ACETABULAR INSERTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130450054S</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:31:43.294Z</lastUpdated>
  </row>
</eudamedExport>