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<eudamedExport entity="devices">
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    <udiDi>00889989053814</udiDi>
    <basicUdiDi>B-00889989053814</basicUdiDi>
    <tradeName>ORTHOS ACCENT LSM 5SGL WDX -10TX22 L</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL WDX -10TX22 L</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0213</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:50.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053784</udiDi>
    <basicUdiDi>B-00889989053784</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX   0TX18 UR/LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX   0TX18 UR/LL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:47.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053807</udiDi>
    <basicUdiDi>B-00889989053807</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL 2ND WDX -10TX18 UR</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND WDX -10TX18 UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0212</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:46.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053791</udiDi>
    <basicUdiDi>B-00889989053791</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL 2ND WDX -10TX22 UR</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND WDX -10TX22 UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0211</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:45.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053777</udiDi>
    <basicUdiDi>B-00889989053777</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX   0TX22 UR/LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX   0TX22 UR/LL</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:29.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053760</udiDi>
    <basicUdiDi>B-00889989053760</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -27TX18 LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -27TX18 LR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0132</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:28.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053753</udiDi>
    <basicUdiDi>B-00889989053753</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -27TX22 LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -27TX22 LR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0131</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:27.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053746</udiDi>
    <basicUdiDi>B-00889989053746</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -22TX18 LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -22TX18 LR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:26.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053739</udiDi>
    <basicUdiDi>B-00889989053739</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -22TX22 LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -22TX22 LR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0121</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:22.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053722</udiDi>
    <basicUdiDi>B-00889989053722</basicUdiDi>
    <tradeName>ORTHOS ACCENT LFM OSGL NDX -10TX18 R</tradeName>
    <deviceName>ORTHOS ACCENT LFM OSGL NDX -10TX18 R</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0118</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:22.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053715</udiDi>
    <basicUdiDi>B-00889989053715</basicUdiDi>
    <tradeName>ORTHOS ACCENT LFM OSGL NDX -10TX22 R</tradeName>
    <deviceName>ORTHOS ACCENT LFM OSGL NDX -10TX22 R</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0117</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:21.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053708</udiDi>
    <basicUdiDi>B-00889989053708</basicUdiDi>
    <tradeName>ORTHOS ACCENT UFS 15SGL NDX -10TX18 R</tradeName>
    <deviceName>ORTHOS ACCENT UFS 15SGL NDX -10TX18 R</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0116</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:18.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053692</udiDi>
    <basicUdiDi>B-00889989053692</basicUdiDi>
    <tradeName>ORTHOS ACCENT UFS 15SGL NDX -10TX22 R</tradeName>
    <deviceName>ORTHOS ACCENT UFS 15SGL NDX -10TX22 R</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0115</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:17.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053685</udiDi>
    <basicUdiDi>B-00889989053685</basicUdiDi>
    <tradeName>ORTHOS ACCENT LSM 5SGL NDX -10TX18 L</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL NDX -10TX18 L</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:16.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053678</udiDi>
    <basicUdiDi>B-00889989053678</basicUdiDi>
    <tradeName>ORTHOS ACCENT LSM 5SGL NDX -10TX22 L</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL NDX -10TX22 L</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:13.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053661</udiDi>
    <basicUdiDi>B-00889989053661</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL 2ND NDX -10TX18 UR</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND NDX -10TX18 UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0112</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:12.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053654</udiDi>
    <basicUdiDi>B-00889989053654</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL 2ND NDX -10TX22 UR</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND NDX -10TX22 UR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>514-0111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:11.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053630</udiDi>
    <basicUdiDi>B-00889989053630</basicUdiDi>
    <tradeName>ORTHOS LSM 6DG -10T B/T NDX  LL  .022</tradeName>
    <deviceName>ORTHOS LSM 6DG -10T B/T NDX  LL  .022</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513-2219</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:07.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053623</udiDi>
    <basicUdiDi>B-00889989053623</basicUdiDi>
    <tradeName>PEERLESS 2ND MOL 6DEG UR NDX-10T X018</tradeName>
    <deviceName>PEERLESS 2ND MOL 6DEG UR NDX-10T X018</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513-2210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:06.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053616</udiDi>
    <basicUdiDi>B-00889989053616</basicUdiDi>
    <tradeName>PEERLESS 2ND MOL 6DEG UR NDX-10T X022</tradeName>
    <deviceName>PEERLESS 2ND MOL 6DEG UR NDX-10T X022</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010402</emdnCode>
    <emdnDescription>ORTHODONTIC BANDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513-2209</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:06.071Z</lastUpdated>
  </row>
</eudamedExport>