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    <tradeName>00889989055078</tradeName>
    <deviceName>ZOO MASTER PACK  5B 3/8  LT  ROADRUNR</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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>630-0014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:20.865Z</lastUpdated>
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  <row>
    <udiDi>00889989055061</udiDi>
    <basicUdiDi>B-00889989055061</basicUdiDi>
    <tradeName>00889989055061</tradeName>
    <deviceName>ZOO MASTER PACK  4B 5/16 LT  PARROT</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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>630-0013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:16.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055054</udiDi>
    <basicUdiDi>B-00889989055054</basicUdiDi>
    <tradeName>00889989055054</tradeName>
    <deviceName>ZOO MASTER PACK  3B 1/4  LT  OWL</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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>630-0012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:16.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055047</udiDi>
    <basicUdiDi>B-00889989055047</basicUdiDi>
    <tradeName>00889989055047</tradeName>
    <deviceName>ZOO MASTER PACK  2B 3/16 LT  QUAIL</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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>630-0011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:15.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055030</udiDi>
    <basicUdiDi>B-00889989055030</basicUdiDi>
    <tradeName>00889989055030</tradeName>
    <deviceName>ZOO MASTER PACK  1B 1/8  LT  HUMMBIRD</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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>630-0010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:14.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055023</udiDi>
    <basicUdiDi>B-00889989055023</basicUdiDi>
    <tradeName>00889989055023</tradeName>
    <deviceName>CRIMPABLE STOP 2MM .030 I.D. X .041 O.D. PK40</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>623-0263</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:10.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055016</udiDi>
    <basicUdiDi>B-00889989055016</basicUdiDi>
    <tradeName>00889989055016</tradeName>
    <deviceName>CRIMPABLE STOP 2MM .019 I.D. X .030 O.D. PK40</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>623-0262</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:09.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055009</udiDi>
    <basicUdiDi>B-00889989055009</basicUdiDi>
    <tradeName>00889989055009</tradeName>
    <deviceName>LINGUAL MOLAR SEATING LUG EACH</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615-0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:08.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054996</udiDi>
    <basicUdiDi>B-00889989054996</basicUdiDi>
    <tradeName>00889989054996</tradeName>
    <deviceName>LINGUAL CUSP BICUSP SEAT LUG EACH</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615-0201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:08.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054989</udiDi>
    <basicUdiDi>B-00889989054989</basicUdiDi>
    <tradeName>00889989054989</tradeName>
    <deviceName>LINGUAL ANT SEATING LUG EACH</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>615-0101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:04.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054972</udiDi>
    <basicUdiDi>B-00889989054972</basicUdiDi>
    <tradeName>00889989054972</tradeName>
    <deviceName>LINGUAL ELASTILUG FLAT EACH</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>614-0022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:03.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054965</udiDi>
    <basicUdiDi>B-00889989054965</basicUdiDi>
    <tradeName>00889989054965</tradeName>
    <deviceName>LINGUAL ELASTILUG CURVED EACH</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>614-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:02.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054958</udiDi>
    <basicUdiDi>B-00889989054958</basicUdiDi>
    <tradeName>00889989054958</tradeName>
    <deviceName>LINGUAL CLEAT -CUSP/BI--STD--</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>613-0012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:41:01.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054941</udiDi>
    <basicUdiDi>B-00889989054941</basicUdiDi>
    <tradeName>00889989054941</tradeName>
    <deviceName>LINGUAL CLEAT --MOLAR--ORMCO--</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>613-0010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:40:57.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054934</udiDi>
    <basicUdiDi>B-00889989054934</basicUdiDi>
    <tradeName>00889989054934</tradeName>
    <deviceName>LINGUAL EYELET EACH</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>612-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:40:56.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054927</udiDi>
    <basicUdiDi>B-00889989054927</basicUdiDi>
    <tradeName>LABIAL/LINGUAL BUTTON-CLEAR PLASTIC</tradeName>
    <deviceName>LABIAL/LINGUAL BUTTON-CLEAR PLASTIC</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>610-0010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:40:56.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054910</udiDi>
    <basicUdiDi>B-00889989054910</basicUdiDi>
    <tradeName>00889989054910</tradeName>
    <deviceName>MOLAR LING BUTTON</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610-0003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:40:55.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054903</udiDi>
    <basicUdiDi>B-00889989054903</basicUdiDi>
    <tradeName>00889989054903</tradeName>
    <deviceName>LINGUAL BUTTON CURVED</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610-0002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:40:51.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054897</udiDi>
    <basicUdiDi>B-00889989054897</basicUdiDi>
    <tradeName>00889989054897</tradeName>
    <deviceName>LINGUAL BUTTON NORMAL</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>610-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:40:50.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989054859</udiDi>
    <basicUdiDi>B-00889989054859</basicUdiDi>
    <tradeName>00889989054859</tradeName>
    <deviceName>CROWN W/CUTOUT-ADVANSYNC 2 L6R SIZE 7 PK5</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>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>600-4337</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:40:49.643Z</lastUpdated>
  </row>
</eudamedExport>