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<eudamedExport entity="devices">
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    <basicUdiDi>B-00889989085860</basicUdiDi>
    <tradeName>L4R DAMON Q2 WELDABLE 022 -5/+4/0 HI TQ</tradeName>
    <deviceName>L4R DAMON Q2 WELDABLE 022 -5/+4/0 HI TQ</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>161-8842</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:19.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085853</udiDi>
    <basicUdiDi>B-00889989085853</basicUdiDi>
    <tradeName>L4L DAMON Q2 WELDABLE 022 -12/+4/0 STD TQ</tradeName>
    <deviceName>L4L DAMON Q2 WELDABLE 022 -12/+4/0 STD TQ</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>161-8841</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:18.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085846</udiDi>
    <basicUdiDi>B-00889989085846</basicUdiDi>
    <tradeName>L4R DAMON Q2 WELDABLE 022 -12/+4/0 STD TQ</tradeName>
    <deviceName>L4R DAMON Q2 WELDABLE 022 -12/+4/0 STD TQ</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>161-8840</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:14.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085822</udiDi>
    <basicUdiDi>B-00889989085822</basicUdiDi>
    <tradeName>00889989085822</tradeName>
    <deviceName>18x25 SMARTARCH CUNITI DAMON LOWER PK10</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>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210-1941</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:12.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085815</udiDi>
    <basicUdiDi>B-00889989085815</basicUdiDi>
    <tradeName>00889989085815</tradeName>
    <deviceName>18x25 SMARTARCH CUNITI DAMON UPPER PK10</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>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210-1931</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:12.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085808</udiDi>
    <basicUdiDi>B-00889989085808</basicUdiDi>
    <tradeName>00889989085808</tradeName>
    <deviceName>16 DIA SMARTARCH CUNITI DAMON LOWER PK10</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>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205-1921</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:11.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085792</udiDi>
    <basicUdiDi>B-00889989085792</basicUdiDi>
    <tradeName>00889989085792</tradeName>
    <deviceName>16 DIA SMARTARCH CUNITI DAMON UPPER PK10</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>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205-1911</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:07.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085785</udiDi>
    <basicUdiDi>B-00889989085785</basicUdiDi>
    <tradeName>00889989085785</tradeName>
    <deviceName>L2L DAMON Q2 022 -6/4/0 STD/LOW TQ</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>491-8827</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:06.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085778</udiDi>
    <basicUdiDi>B-00889989085778</basicUdiDi>
    <tradeName>00889989085778</tradeName>
    <deviceName>L2R DAMON Q2 022 -6/4/0 STD/LOW TQ</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>491-8826</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:05.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085761</udiDi>
    <basicUdiDi>B-00889989085761</basicUdiDi>
    <tradeName>00889989085761</tradeName>
    <deviceName>L1L DAMON Q2 022 -6/2/0 STD/LOW TQ</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>491-8817</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:04.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085754</udiDi>
    <basicUdiDi>B-00889989085754</basicUdiDi>
    <tradeName>00889989085754</tradeName>
    <deviceName>L1R DAMON Q2 022 -6/2/0 STD/LOW TQ</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>491-8816</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:00.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085075</udiDi>
    <basicUdiDi>B-00889989085075</basicUdiDi>
    <tradeName>MINI 2000 U/L 5-5 STD TQ WITH HK(.022)</tradeName>
    <deviceName>MINI 2000 U/L 5-5 STD TQ WITH HK(.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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-1519</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:57:00.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085068</udiDi>
    <basicUdiDi>B-00889989085068</basicUdiDi>
    <tradeName>MINI DIAMOND U/L 5-5 STD TQ WITH HK(.022)</tradeName>
    <deviceName>MINI DIAMOND U/L 5-5 STD TQ WITH HK(.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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-1517</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:58.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085051</udiDi>
    <basicUdiDi>B-00889989085051</basicUdiDi>
    <tradeName>MINI DIAMOND U/L 5-5 HIGH TQ WITH HK(.022)</tradeName>
    <deviceName>MINI DIAMOND U/L 5-5 HIGH TQ WITH HK(.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>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740-1516</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:57.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085037</udiDi>
    <basicUdiDi>B-00889989085037</basicUdiDi>
    <tradeName>DC2 U2-2 LOW TQ, U3 STD TQ; DC U4&amp;5/L3-3 STD TQ; DQ L4&amp;5 STD TQ</tradeName>
    <deviceName>DC2 U2-2 LOW TQ, U3 STD TQ; DC U4&amp;5/L3-3 STD TQ; DQ L4&amp;5 STD TQ</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>740-1513</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:53.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085020</udiDi>
    <basicUdiDi>B-00889989085020</basicUdiDi>
    <tradeName>DC2 U3-3 HIGH TQ; DC U4&amp;5/L3-3 STD TQ;DQ L4&amp;5 STD TQ</tradeName>
    <deviceName>DC2 U3-3 HIGH TQ; DC U4&amp;5/L3-3 STD TQ;DQ L4&amp;5 STD TQ</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>740-1512</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:52.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085013</udiDi>
    <basicUdiDi>B-00889989085013</basicUdiDi>
    <tradeName>DQ U3-3/L3&amp;4 HIGH TQ, U4&amp;5 / L1&amp;2&amp;5 STD TQ</tradeName>
    <deviceName>DQ U3-3/L3&amp;4 HIGH TQ, U4&amp;5 / L1&amp;2&amp;5 STD TQ</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>740-1511</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:52.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989085006</udiDi>
    <basicUdiDi>B-00889989085006</basicUdiDi>
    <tradeName>DQ U3-3/L3-3 LOW TQ, U4&amp;5/L 4&amp;5 STD TQ</tradeName>
    <deviceName>DQ U3-3/L3-3 LOW TQ, U4&amp;5/L 4&amp;5 STD TQ</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>740-1510</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:51.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989084993</udiDi>
    <basicUdiDi>B-00889989084993</basicUdiDi>
    <tradeName>DQ U3-3 HIGH TQ, U4&amp;5 STD TQ, L 3-3 LOW TQ, L4&amp;5 STD TQ</tradeName>
    <deviceName>DQ U3-3 HIGH TQ, U4&amp;5 STD TQ, L 3-3 LOW TQ, L4&amp;5 STD TQ</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>740-1509</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:47.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989084061</udiDi>
    <basicUdiDi>B-00889989084061</basicUdiDi>
    <tradeName>00889989084061</tradeName>
    <deviceName>U4&amp;5L DAMON Q2 G-OFF 022 -11/+2/0 STD TQ - HOOK</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>491-9991</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:56:46.475Z</lastUpdated>
  </row>
</eudamedExport>