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    <tradeName>L6R SL B/T ORTHOS .022 FLG -22/0/0</tradeName>
    <deviceName>L6R SL B/T ORTHOS .022 FLG -22/0/0</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513-1252</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:17.990Z</lastUpdated>
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  <row>
    <udiDi>00889989053395</udiDi>
    <basicUdiDi>B-00889989053395</basicUdiDi>
    <tradeName>L6L SL B/T ORTHOS .022 FLG -22/0/0</tradeName>
    <deviceName>L6L SL B/T ORTHOS .022 FLG -22/0/0</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>513-1251</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:17.189Z</lastUpdated>
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  <row>
    <udiDi>00889989053388</udiDi>
    <basicUdiDi>B-00889989053388</basicUdiDi>
    <tradeName>U6R SL B/T DAMON .022 FLG -18/0/+12</tradeName>
    <deviceName>U6R SL B/T DAMON .022 FLG -18/0/+12</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>513-1244</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:15.594Z</lastUpdated>
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  <row>
    <udiDi>00889989053371</udiDi>
    <basicUdiDi>B-00889989053371</basicUdiDi>
    <tradeName>U6L SL B/T DAMON .022 FLG -18/0/+12</tradeName>
    <deviceName>U6L SL B/T DAMON .022 FLG -18/0/+12</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>513-1243</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:13.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053364</udiDi>
    <basicUdiDi>B-00889989053364</basicUdiDi>
    <tradeName>L6R SL B/T DAMON .022 FLG -28/+2/+2</tradeName>
    <deviceName>L6R SL B/T DAMON .022 FLG -28/+2/+2</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>513-1242</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:11.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053357</udiDi>
    <basicUdiDi>B-00889989053357</basicUdiDi>
    <tradeName>L6L SL B/T DAMON .022 FLG -28/+2/+2</tradeName>
    <deviceName>L6L SL B/T DAMON .022 FLG -28/+2/+2</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>513-1241</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:10.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053340</udiDi>
    <basicUdiDi>B-00889989053340</basicUdiDi>
    <tradeName>PRLS 2ND MOL 6DEG N/HOOK 10TRQX022 LT</tradeName>
    <deviceName>PRLS 2ND MOL 6DEG N/HOOK 10TRQX022 LT</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512-2309</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:09.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053333</udiDi>
    <basicUdiDi>B-00889989053333</basicUdiDi>
    <tradeName>ORTHOS LSM 6DG -10T B/T NDX  LR  .018</tradeName>
    <deviceName>ORTHOS LSM 6DG -10T B/T NDX  LR  .018</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>512-2220</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:06.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053326</udiDi>
    <basicUdiDi>B-00889989053326</basicUdiDi>
    <tradeName>ORTHOS LSM 6DG -10T B/T NDX  LR  .022</tradeName>
    <deviceName>ORTHOS LSM 6DG -10T B/T NDX  LR  .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>512-2219</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:05.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053319</udiDi>
    <basicUdiDi>B-00889989053319</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG UL NDX-10T X 018</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG UL NDX-10T X 018</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>512-2210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:04.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053302</udiDi>
    <basicUdiDi>B-00889989053302</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG UL NDX-10T X 022</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG UL NDX-10T X 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>512-2209</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:02.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053296</udiDi>
    <basicUdiDi>B-00889989053296</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG   LL NDX-27TX018</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG   LL NDX-27TX018</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>512-2206</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:34:00.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053289</udiDi>
    <basicUdiDi>B-00889989053289</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG   LL NDX-27TX022</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG   LL NDX-27TX022</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>512-2205</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:58.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053272</udiDi>
    <basicUdiDi>B-00889989053272</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG   LL NDX-20TX018</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG   LL NDX-20TX018</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>512-2204</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:57.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053265</udiDi>
    <basicUdiDi>B-00889989053265</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG   LL NDX-2OTX022</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG   LL NDX-2OTX022</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>512-2203</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:56.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053258</udiDi>
    <basicUdiDi>B-00889989053258</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG UR/LL NDX OTX018</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG UR/LL NDX OTX018</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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>512-2202</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:53.973Z</lastUpdated>
  </row>
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    <udiDi>00889989053241</udiDi>
    <basicUdiDi>B-00889989053241</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG UR/LL NDX 0TX022</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG UR/LL NDX 0TX022</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>512-2201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:52.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053234</udiDi>
    <basicUdiDi>B-00889989053234</basicUdiDi>
    <tradeName>ORTHOS LSM 6DG -10T B/T WDX  LR  .018</tradeName>
    <deviceName>ORTHOS LSM 6DG -10T B/T WDX  LR  .018</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>512-2120</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:51.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989053227</udiDi>
    <basicUdiDi>B-00889989053227</basicUdiDi>
    <tradeName>ORTHOS LSM 6DG -10T B/T WDX  LR  .022</tradeName>
    <deviceName>ORTHOS LSM 6DG -10T B/T WDX  LR  .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>512-2119</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:49.974Z</lastUpdated>
  </row>
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    <udiDi>00889989053210</udiDi>
    <basicUdiDi>B-00889989053210</basicUdiDi>
    <tradeName>PEERLESS 2NDMOL 6DEG UL WDX-10T X 018</tradeName>
    <deviceName>PEERLESS 2NDMOL 6DEG UL WDX-10T X 018</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>512-2110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:33:47.570Z</lastUpdated>
  </row>
</eudamedExport>