<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00889989055474</udiDi>
    <basicUdiDi>B-00889989055474</basicUdiDi>
    <tradeName>00889989055474</tradeName>
    <deviceName>COLOR MASTER PACK - 2D 3/16 RABBIT</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>636-0114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:50.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055467</udiDi>
    <basicUdiDi>B-00889989055467</basicUdiDi>
    <tradeName>00889989055467</tradeName>
    <deviceName>COLOR MASTER PACK - 1D 1/8  CHIPMUNK</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>636-0113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:46.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055450</udiDi>
    <basicUdiDi>B-00889989055450</basicUdiDi>
    <tradeName>00889989055450</tradeName>
    <deviceName>MASTER POUCH 15  6H 1/2  HVY WHALE</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>635-0067</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:45.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055443</udiDi>
    <basicUdiDi>B-00889989055443</basicUdiDi>
    <tradeName>00889989055443</tradeName>
    <deviceName>MASTER POUCH 15  5H 3/8  HVY ELEPHNT</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>635-0066</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:45.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055436</udiDi>
    <basicUdiDi>B-00889989055436</basicUdiDi>
    <tradeName>00889989055436</tradeName>
    <deviceName>MASTER POUCH 15  4H 5/16 HVY WALRUS</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>635-0065</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:44.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055429</udiDi>
    <basicUdiDi>B-00889989055429</basicUdiDi>
    <tradeName>00889989055429</tradeName>
    <deviceName>MASTER POUCH 15  6G 1/2  LT  LION</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>635-0062</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:28.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055412</udiDi>
    <basicUdiDi>B-00889989055412</basicUdiDi>
    <tradeName>00889989055412</tradeName>
    <deviceName>MASTER POUCH 15  5G 3/8  LT  TIGER</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>635-0061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:28.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055405</udiDi>
    <basicUdiDi>B-00889989055405</basicUdiDi>
    <tradeName>00889989055405</tradeName>
    <deviceName>MASTER POUCH 15  4G 5/16 LT  PANTHER</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>635-0060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:24.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055399</udiDi>
    <basicUdiDi>B-00889989055399</basicUdiDi>
    <tradeName>00889989055399</tradeName>
    <deviceName>MASTER POUCH 15  3G 1/4  LT  LEOPARD</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>635-0059</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:23.393Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055382</udiDi>
    <basicUdiDi>B-00889989055382</basicUdiDi>
    <tradeName>00889989055382</tradeName>
    <deviceName>MASTER POUCH 15  2G 3/16 LT  COUGAR</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>635-0058</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:22.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055375</udiDi>
    <basicUdiDi>B-00889989055375</basicUdiDi>
    <tradeName>00889989055375</tradeName>
    <deviceName>ZOO MASTER POUCH 6H 1/2  14OZ WHALE</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>634-0014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:21.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055368</udiDi>
    <basicUdiDi>B-00889989055368</basicUdiDi>
    <tradeName>00889989055368</tradeName>
    <deviceName>ZOO MASTER POUCH 4H 5/16 14OZ WALRUS</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>634-0012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:17.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055351</udiDi>
    <basicUdiDi>B-00889989055351</basicUdiDi>
    <tradeName>00889989055351</tradeName>
    <deviceName>ZOO MASTER POUCH 6G 1/2  8OZ LION</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>634-0004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:16.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055344</udiDi>
    <basicUdiDi>B-00889989055344</basicUdiDi>
    <tradeName>00889989055344</tradeName>
    <deviceName>ZOO MASTER POUCH 5G 3/8  8OZ TIGER</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>634-0003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:16.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055337</udiDi>
    <basicUdiDi>B-00889989055337</basicUdiDi>
    <tradeName>00889989055337</tradeName>
    <deviceName>ZOO MASTER POUCH 4G 5/16 8OZ PANTHER</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>634-0002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:15.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055320</udiDi>
    <basicUdiDi>B-00889989055320</basicUdiDi>
    <tradeName>00889989055320</tradeName>
    <deviceName>ZOO MASTER POUCH 3G 1/4  8OZ LEOPARD</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>634-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:11.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055313</udiDi>
    <basicUdiDi>B-00889989055313</basicUdiDi>
    <tradeName>00889989055313</tradeName>
    <deviceName>ZOO MASTER POUCH 2G 3/16 8OZ COUGAR</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>634-0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:10.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055306</udiDi>
    <basicUdiDi>B-00889989055306</basicUdiDi>
    <tradeName>00889989055306</tradeName>
    <deviceName>ZOO MASTER PACK  5F 3/8  E/H BUFFALO</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>630-0053</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:09.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055290</udiDi>
    <basicUdiDi>B-00889989055290</basicUdiDi>
    <tradeName>00889989055290</tradeName>
    <deviceName>ZOO MASTER PACK  4F 5/16 E/H MOOSE</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>630-0052</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:08.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989055283</udiDi>
    <basicUdiDi>B-00889989055283</basicUdiDi>
    <tradeName>00889989055283</tradeName>
    <deviceName>ZOO MASTER PACK  3F 1/4  E/H RAM</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>630-0051</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:04.975Z</lastUpdated>
  </row>
</eudamedExport>