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    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅰ)</tradeName>
    <deviceName>Spinal Fixation Surgical Instrument</deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107-360</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:11:02.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939263885052</udiDi>
    <basicUdiDi>B-06939263885052</basicUdiDi>
    <tradeName>COX Monoaxial Pedicle Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19900156</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:54:56.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939263885069</udiDi>
    <basicUdiDi>B-06939263885069</basicUdiDi>
    <tradeName>COX Monoaxial Pedicle Screw</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THORACOLUMBOSACRAL FIXATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>19900157</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:54:56.241Z</lastUpdated>
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  <row>
    <udiDi>06936745120625</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅰ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0925</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107-149</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.881Z</lastUpdated>
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  <row>
    <udiDi>06936745120632</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅰ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0925</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1060005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120649</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅰ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0925</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.843Z</lastUpdated>
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  <row>
    <udiDi>06936745120656</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅰ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0925</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120663</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅱ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113-013</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120670</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅲ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>313-130</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120687</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅲ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103-018</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120700</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅳ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107-400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120717</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅴ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110-200</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120724</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅵ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>313-120</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120748</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Open Drill (Ⅶ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>201101</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120755</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Reamer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107-156</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120762</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Reamer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010015</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120779</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Reamer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1010016</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120809</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Reamer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-209</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120816</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Tap (Ⅰ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113-530</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936745120823</udiDi>
    <basicUdiDi>69367451SFSI01WJ</basicUdiDi>
    <tradeName>Tap (Ⅰ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Beijing Fule Science &amp; Technology Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006511</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0925</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>113-531</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:56.558Z</lastUpdated>
  </row>
</eudamedExport>