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<eudamedExport entity="devices">
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    <udiDi>00889989054019</udiDi>
    <basicUdiDi>B-00889989054019</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL 2ND WDX -10TX22 UL</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND WDX -10TX22 UL</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>515-0211</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:07.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054002</udiDi>
    <basicUdiDi>B-00889989054002</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX   0TX18 UL/LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX   0TX18 UL/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>515-0202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:05.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053999</udiDi>
    <basicUdiDi>B-00889989053999</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX 0TX22 UL/LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX 0TX22 UL/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>515-0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:38:04.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053982</udiDi>
    <basicUdiDi>B-00889989053982</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -27TX18 LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -27TX18 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>515-0132</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:15.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053975</udiDi>
    <basicUdiDi>B-00889989053975</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -27TX22 LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -27TX22 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>515-0131</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:14.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053968</udiDi>
    <basicUdiDi>B-00889989053968</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -22TX18 LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -22TX18 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>515-0122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:13.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053951</udiDi>
    <basicUdiDi>B-00889989053951</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S NDX -22TX22 LL</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S NDX -22TX22 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>515-0121</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:11.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053944</udiDi>
    <basicUdiDi>B-00889989053944</basicUdiDi>
    <tradeName>ORTHOS ACCENT LFM OSGL NDX -10TX18 L</tradeName>
    <deviceName>ORTHOS ACCENT LFM OSGL 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>515-0118</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:10.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053937</udiDi>
    <basicUdiDi>B-00889989053937</basicUdiDi>
    <tradeName>ORTHOS ACCENT LFM OSGL NDX -10TX22 L</tradeName>
    <deviceName>ORTHOS ACCENT LFM OSGL 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>515-0117</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:09.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053920</udiDi>
    <basicUdiDi>B-00889989053920</basicUdiDi>
    <tradeName>ORTHOS ACCENT UFS 15SGL NDX -10TX18 L</tradeName>
    <deviceName>ORTHOS ACCENT UFS 15SGL 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>515-0116</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:06.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053913</udiDi>
    <basicUdiDi>B-00889989053913</basicUdiDi>
    <tradeName>ORTHOS ACCENT UFS 15SGL NDX -10TX22 L</tradeName>
    <deviceName>ORTHOS ACCENT UFS 15SGL 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>515-0115</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:05.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053906</udiDi>
    <basicUdiDi>B-00889989053906</basicUdiDi>
    <tradeName>ORTHOS ACCENT LSM 5SGL NDX -10TX18 R</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL 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>515-0114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:04.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053890</udiDi>
    <basicUdiDi>B-00889989053890</basicUdiDi>
    <tradeName>ORTHOS ACCENT LSM 5SGL NDX -10TX22 R</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL 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>515-0113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:02.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053883</udiDi>
    <basicUdiDi>B-00889989053883</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL 2ND NDX -10TX18 UL</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND NDX -10TX18 UL</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>515-0112</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:36:00.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053876</udiDi>
    <basicUdiDi>B-00889989053876</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL 2ND NDX -10TX22 UL</tradeName>
    <deviceName>ACCENT B/T 5SGL 2ND NDX -10TX22 UL</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>515-0111</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:58.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053869</udiDi>
    <basicUdiDi>B-00889989053869</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX -27TX18 LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX -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>514-0232</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:58.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053852</udiDi>
    <basicUdiDi>B-00889989053852</basicUdiDi>
    <tradeName>ACCENT B/T 5SGL F/S WDX -27TX22 LR</tradeName>
    <deviceName>ACCENT B/T 5SGL F/S WDX -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>514-0231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:56.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053845</udiDi>
    <basicUdiDi>B-00889989053845</basicUdiDi>
    <tradeName>ORTHOS ACCENT USM 15SGL WDX -10TX18 R</tradeName>
    <deviceName>ORTHOS ACCENT USM 15SGL WDX -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>514-0216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:54.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053838</udiDi>
    <basicUdiDi>B-00889989053838</basicUdiDi>
    <tradeName>ORTHOS ACCENT USM 15SGL WDX -10TX22 R</tradeName>
    <deviceName>ORTHOS ACCENT USM 15SGL WDX -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>514-0215</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:52.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053821</udiDi>
    <basicUdiDi>B-00889989053821</basicUdiDi>
    <tradeName>ORTHOS ACCENT LSM 5SGL WDX -10TX18 L</tradeName>
    <deviceName>ORTHOS ACCENT LSM 5SGL WDX -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>514-0214</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:35:51.755Z</lastUpdated>
  </row>
</eudamedExport>