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    <deviceName>POWER CHAIN  II  CLEAR OPEN 15FT 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>639-0013</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:22.663Z</lastUpdated>
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    <udiDi>00889989055665</udiDi>
    <basicUdiDi>B-00889989055665</basicUdiDi>
    <tradeName>00889989055665</tradeName>
    <deviceName>POWER CHAIN  I   CLEAR WIDE 15FT 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>639-0012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:18.658Z</lastUpdated>
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    <udiDi>00889989055658</udiDi>
    <basicUdiDi>B-00889989055658</basicUdiDi>
    <tradeName>00889989055658</tradeName>
    <deviceName>POWER CHAIN II   GRAY  OPEN 15FT 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>639-0011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>00889989055641</udiDi>
    <basicUdiDi>B-00889989055641</basicUdiDi>
    <tradeName>00889989055641</tradeName>
    <deviceName>POWER CHAIN  I   GRAY  WIDE 15FT 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>639-0010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:17.059Z</lastUpdated>
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    <udiDi>00889989055634</udiDi>
    <basicUdiDi>B-00889989055634</basicUdiDi>
    <tradeName>00889989055634</tradeName>
    <deviceName>POWER CHAIN -GEN II-CLEAR   OPEN LINK</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>639-0004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:16.275Z</lastUpdated>
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    <udiDi>00889989055627</udiDi>
    <basicUdiDi>B-00889989055627</basicUdiDi>
    <tradeName>00889989055627</tradeName>
    <deviceName>POWER CHAIN -GEN II- GRAY   OPEN LINK</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>639-0003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:12.255Z</lastUpdated>
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    <udiDi>00889989055610</udiDi>
    <basicUdiDi>B-00889989055610</basicUdiDi>
    <tradeName>00889989055610</tradeName>
    <deviceName>POWER CHAIN -GEN II-CLEAR CLOSED LINK</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>639-0002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:11.455Z</lastUpdated>
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    <udiDi>00889989055603</udiDi>
    <basicUdiDi>B-00889989055603</basicUdiDi>
    <tradeName>00889989055603</tradeName>
    <deviceName>POWER CHAIN -GEN II- GRAY CLOSED LINK</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>639-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:10.684Z</lastUpdated>
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  <row>
    <udiDi>00889989055597</udiDi>
    <basicUdiDi>B-00889989055597</basicUdiDi>
    <tradeName>00889989055597</tradeName>
    <deviceName>DAMON TIEBACK MODULE SZ 2 CLEAR 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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>637-0022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:09.863Z</lastUpdated>
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    <udiDi>00889989055580</udiDi>
    <basicUdiDi>B-00889989055580</basicUdiDi>
    <tradeName>00889989055580</tradeName>
    <deviceName>DAMON TIEBACK MODULE SZ 2 GRAY 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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>637-0021</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:05.851Z</lastUpdated>
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    <udiDi>00889989055573</udiDi>
    <basicUdiDi>B-00889989055573</basicUdiDi>
    <tradeName>00889989055573</tradeName>
    <deviceName>DAMON TIEBACK MODULE SZ 1 CLEAR 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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>637-0012</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:05.051Z</lastUpdated>
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    <udiDi>00889989055566</udiDi>
    <basicUdiDi>B-00889989055566</basicUdiDi>
    <tradeName>00889989055566</tradeName>
    <deviceName>DAMON TIEBACK MODULE SZ 1 GRAY 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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>637-0011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:04.247Z</lastUpdated>
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    <udiDi>00889989055559</udiDi>
    <basicUdiDi>B-00889989055559</basicUdiDi>
    <tradeName>00889989055559</tradeName>
    <deviceName>COLOR MASTER PACK - 5F 3/8  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>636-0128</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:43:03.482Z</lastUpdated>
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    <udiDi>00889989055542</udiDi>
    <basicUdiDi>B-00889989055542</basicUdiDi>
    <tradeName>00889989055542</tradeName>
    <deviceName>COLOR MASTER PACK - 4F 5/16 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>636-0127</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:59.449Z</lastUpdated>
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    <udiDi>00889989055535</udiDi>
    <basicUdiDi>B-00889989055535</basicUdiDi>
    <tradeName>00889989055535</tradeName>
    <deviceName>COLOR MASTER PACK - 3F 1/4  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>636-0126</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:58.645Z</lastUpdated>
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    <udiDi>00889989055528</udiDi>
    <basicUdiDi>B-00889989055528</basicUdiDi>
    <tradeName>00889989055528</tradeName>
    <deviceName>COLOR MASTER PACK - 2F 3/16 IMPALA</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>636-0125</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:57.846Z</lastUpdated>
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    <udiDi>00889989055511</udiDi>
    <basicUdiDi>B-00889989055511</basicUdiDi>
    <tradeName>00889989055511</tradeName>
    <deviceName>COLOR MASTER PACK - 3E 1/4  BEAR</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>636-0122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:57.049Z</lastUpdated>
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    <udiDi>00889989055504</udiDi>
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    <tradeName>00889989055504</tradeName>
    <deviceName>COLOR MASTER PACK - 5D 3/8  MONKEY</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>636-0117</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:53.043Z</lastUpdated>
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    <tradeName>00889989055498</tradeName>
    <deviceName>COLOR MASTER PACK - 4D 5/16 PENGUIN</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>636-0116</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:52.243Z</lastUpdated>
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    <tradeName>00889989055481</tradeName>
    <deviceName>COLOR MASTER PACK - 3D 1/4  FOX</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>636-0115</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T12:42:51.444Z</lastUpdated>
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