<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06950292630222</udiDi>
    <basicUdiDi>B-06950292630222</basicUdiDi>
    <tradeName>06950292630222</tradeName>
    <deviceName>KALEIDO MANDIBLE U-Plate, small, 40.5*203.3mm, Thickness 2.0mm, 4+20+4 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114122001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:15:06.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630185</udiDi>
    <basicUdiDi>B-06950292630185</basicUdiDi>
    <tradeName>06950292630185</tradeName>
    <deviceName>KALEIDO MANDIBLE Straight Plate, 6.7*158.7mm, Thickness 2.0mm, 20 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114072003</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:15:00.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630178</udiDi>
    <basicUdiDi>B-06950292630178</basicUdiDi>
    <tradeName>06950292630178</tradeName>
    <deviceName>KALEIDO MANDIBLE Straight Plate, 6.7*94.7mm, Thickness 2.0mm, 12 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114072002</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:59.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630161</udiDi>
    <basicUdiDi>B-06950292630161</basicUdiDi>
    <tradeName>06950292630161</tradeName>
    <deviceName>KALEIDO MANDIBLE Straight Plate, 6.7*46.7mm,Thickness 2.0mm, 6 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114072001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:58.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630154</udiDi>
    <basicUdiDi>B-06950292630154</basicUdiDi>
    <tradeName>06950292630154</tradeName>
    <deviceName>KALEIDO MANDIBLE Crescent Plate, 10.7*49.9mm, Thickness 1.5mm, 6 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114031502</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:57.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630130</udiDi>
    <basicUdiDi>B-06950292630130</basicUdiDi>
    <tradeName>06950292630130</tradeName>
    <deviceName>KALEIDO MANDIBLE Straight Plate, 6.8*158.8mm, Thickness 1.5mm, 20 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071504</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:51.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630123</udiDi>
    <basicUdiDi>B-06950292630123</basicUdiDi>
    <tradeName>06950292630123</tradeName>
    <deviceName>KALEIDO MANDIBLE Straight Plate, 6.8*94.8mm, Thickness 1.5mm, 12 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071503</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:50.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630116</udiDi>
    <basicUdiDi>B-06950292630116</basicUdiDi>
    <tradeName>06950292630116</tradeName>
    <deviceName>KALEIDO MANDIBLE Straight Plate, 6.8*46.8mm, Thickness 1.5mm, 6 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071501</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:48.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630109</udiDi>
    <basicUdiDi>B-06950292630109</basicUdiDi>
    <tradeName>06950292630109</tradeName>
    <deviceName>KALEIDO MANDIBLE Adaption Plate, 5.2*71.2mm, Thickness 1.25mm, 12 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071201</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:47.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630062</udiDi>
    <basicUdiDi>B-06950292630062</basicUdiDi>
    <tradeName>06950292630062</tradeName>
    <deviceName>KALEIDO MANDIBLE Adaption Plate, 5.0*119.0mm, Thickness 1.0mm, 20 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071007</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:41.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630055</udiDi>
    <basicUdiDi>B-06950292630055</basicUdiDi>
    <tradeName>06950292630055</tradeName>
    <deviceName>KALEIDO MANDIBLE Adaption Plate, 5.0*71.0mm, Thickness 1.0mm, 12 Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071006</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:40.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630048</udiDi>
    <basicUdiDi>B-06950292630048</basicUdiDi>
    <tradeName>06950292630048</tradeName>
    <deviceName>KALEIDO MANDIBLE Mini Tension Band Plate,broad,5.0*35.0mm, Thickness1.0mm,6Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071005</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:39.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630031</udiDi>
    <basicUdiDi>B-06950292630031</basicUdiDi>
    <tradeName>06950292630031</tradeName>
    <deviceName>KALEIDO MANDIBLE Mini Tension Band Plate,broad,5.0*29.9mm,Thickness1.0mm,5Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071004</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:38.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630024</udiDi>
    <basicUdiDi>B-06950292630024</basicUdiDi>
    <tradeName>06950292630024</tradeName>
    <deviceName>KALEIDO MANDIBLE Mini Tension Band Plate,broad,5.0*24.8mm,Thickness1.0mm,4Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071003</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:32.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292630000</udiDi>
    <basicUdiDi>B-06950292630000</basicUdiDi>
    <tradeName>06950292630000</tradeName>
    <deviceName>KALEIDO MANDIBLE Mini Tension Band Plate,narrow,5.0*29.1mm,Thickness1.0mm,4Holes</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120501</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS COMPRESSION PLATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A1114071001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:30.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292629974</udiDi>
    <basicUdiDi>B-06950292629974</basicUdiDi>
    <tradeName>06950292629974</tradeName>
    <deviceName>KALEIDO 2.9mm Locking Screw, self-tapping, 16mm</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A2210312916</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:29.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292629967</udiDi>
    <basicUdiDi>B-06950292629967</basicUdiDi>
    <tradeName>06950292629967</tradeName>
    <deviceName>KALEIDO 2.9mm Locking Screw, self-tapping, 14mm</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A2210312914</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:28.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292629950</udiDi>
    <basicUdiDi>B-06950292629950</basicUdiDi>
    <tradeName>06950292629950</tradeName>
    <deviceName>KALEIDO 2.9mm Locking Screw, self-tapping, 12mm</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A2210312912</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:22.408Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292629943</udiDi>
    <basicUdiDi>B-06950292629943</basicUdiDi>
    <tradeName>06950292629943</tradeName>
    <deviceName>KALEIDO 2.9mm Locking Screw, self-tapping, 10mm</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A2210312910</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:21.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292629936</udiDi>
    <basicUdiDi>B-06950292629936</basicUdiDi>
    <tradeName>06950292629936</tradeName>
    <deviceName>KALEIDO 2.9mm Locking Screw, self-tapping, 8mm</deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2A2210312908</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T04:14:20.010Z</lastUpdated>
  </row>
</eudamedExport>