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    <tradeName>00889989056495</tradeName>
    <deviceName>POWER TUBE   025 GRAY  25FT PKG ASSY</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>640-4025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:47:00.125Z</lastUpdated>
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    <udiDi>00889989056488</udiDi>
    <basicUdiDi>B-00889989056488</basicUdiDi>
    <tradeName>00889989056488</tradeName>
    <deviceName>POWER THREAD CLEAR 030DIA 50FT SPOOL</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>640-2031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:59.325Z</lastUpdated>
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    <udiDi>00889989056471</udiDi>
    <basicUdiDi>B-00889989056471</basicUdiDi>
    <tradeName>00889989056471</tradeName>
    <deviceName>POWER THREAD GRAY  030DIA 50FT SPOOL</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>640-2030</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:58.519Z</lastUpdated>
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    <udiDi>00889989056464</udiDi>
    <basicUdiDi>B-00889989056464</basicUdiDi>
    <tradeName>00889989056464</tradeName>
    <deviceName>POWER THREAD CLEAR 025DIA 50FT SPOOL</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>640-2026</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:57.710Z</lastUpdated>
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    <udiDi>00889989056457</udiDi>
    <basicUdiDi>B-00889989056457</basicUdiDi>
    <tradeName>00889989056457</tradeName>
    <deviceName>POWER THREAD GRAY  025DIA 50FT SPOOL</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>640-2025</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:53.728Z</lastUpdated>
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    <udiDi>00889989056433</udiDi>
    <basicUdiDi>B-00889989056433</basicUdiDi>
    <tradeName>00889989056433</tradeName>
    <deviceName>SHORT STICK METALLIC SAMPLER PK1000</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>640-1271</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:52.920Z</lastUpdated>
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    <udiDi>00889989056426</udiDi>
    <basicUdiDi>B-00889989056426</basicUdiDi>
    <tradeName>00889989056426</tradeName>
    <deviceName>SHORT STICK REGULAR SAMPLER PK1000</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>640-1270</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:52.120Z</lastUpdated>
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    <udiDi>00889989056419</udiDi>
    <basicUdiDi>B-00889989056419</basicUdiDi>
    <tradeName>00889989056419</tradeName>
    <deviceName>POWER O SHORT STICK .120 GREY 1000/PACK</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>640-1265</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:51.328Z</lastUpdated>
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    <udiDi>00889989056402</udiDi>
    <basicUdiDi>B-00889989056402</basicUdiDi>
    <tradeName>00889989056402</tradeName>
    <deviceName>POWER O SHORT STICK .120 CLEAR 1000/PACK</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>640-1264</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:47.314Z</lastUpdated>
  </row>
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    <udiDi>00889989056396</udiDi>
    <basicUdiDi>B-00889989056396</basicUdiDi>
    <tradeName>00889989056396</tradeName>
    <deviceName>POWER O SHORT STICK .120 SMOKE PACK1000</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>640-1263</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:46.633Z</lastUpdated>
  </row>
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    <udiDi>00889989056389</udiDi>
    <basicUdiDi>B-00889989056389</basicUdiDi>
    <tradeName>00889989056389</tradeName>
    <deviceName>POWER O SHORT STICK .120 NAVY PACK1000</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>640-1262</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:44.917Z</lastUpdated>
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    <udiDi>00889989056372</udiDi>
    <basicUdiDi>B-00889989056372</basicUdiDi>
    <tradeName>00889989056372</tradeName>
    <deviceName>POWER O SHORT STICK .120 COBALT PACK1000</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>640-1261</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:44.108Z</lastUpdated>
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    <udiDi>00889989056365</udiDi>
    <basicUdiDi>B-00889989056365</basicUdiDi>
    <tradeName>00889989056365</tradeName>
    <deviceName>POWER O SHORT STICK .120 RUBY RED PACK1000</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>640-1260</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:40.102Z</lastUpdated>
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    <udiDi>00889989056358</udiDi>
    <basicUdiDi>B-00889989056358</basicUdiDi>
    <tradeName>00889989056358</tradeName>
    <deviceName>POWER O SHORT STICK .120 JADE PACK1000</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>640-1259</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:39.300Z</lastUpdated>
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    <udiDi>00889989056341</udiDi>
    <basicUdiDi>B-00889989056341</basicUdiDi>
    <tradeName>00889989056341</tradeName>
    <deviceName>POWER O SHORT STICK .120 SILVER PACK1000</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>640-1258</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:38.509Z</lastUpdated>
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    <udiDi>00889989056334</udiDi>
    <basicUdiDi>B-00889989056334</basicUdiDi>
    <tradeName>00889989056334</tradeName>
    <deviceName>POWER O SHORT STICK .120 GOLD  PACK1000</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>640-1257</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:37.697Z</lastUpdated>
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    <udiDi>00889989056327</udiDi>
    <basicUdiDi>B-00889989056327</basicUdiDi>
    <tradeName>00889989056327</tradeName>
    <deviceName>POWER O SHORT STICK .120 MAROON  PACK1000</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>640-1256</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:33.698Z</lastUpdated>
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    <udiDi>00889989056310</udiDi>
    <basicUdiDi>B-00889989056310</basicUdiDi>
    <tradeName>00889989056310</tradeName>
    <deviceName>POWER O SHORT STICK .120 EMERALD PACK1000</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>640-1255</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:32.893Z</lastUpdated>
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    <udiDi>00889989056303</udiDi>
    <basicUdiDi>B-00889989056303</basicUdiDi>
    <tradeName>00889989056303</tradeName>
    <deviceName>POWER O SHORT STICK .120 VIOLET PACK1000</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>640-1252</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:32.094Z</lastUpdated>
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    <udiDi>00889989056297</udiDi>
    <basicUdiDi>B-00889989056297</basicUdiDi>
    <tradeName>00889989056297</tradeName>
    <deviceName>POWER O SHORT STICK .120 ROSE PACK1000</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>640-1251</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:46:31.382Z</lastUpdated>
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