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    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.407Z</lastUpdated>
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    <udiDi>04560231202063</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OB1 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.392Z</lastUpdated>
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    <udiDi>04560231202070</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OB2 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.377Z</lastUpdated>
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    <udiDi>04560231202087</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OB3 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.365Z</lastUpdated>
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    <udiDi>04560231202094</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OB4 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.347Z</lastUpdated>
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    <udiDi>04560231202100</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OC1 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.328Z</lastUpdated>
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    <udiDi>04560231202117</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OC2 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.310Z</lastUpdated>
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    <udiDi>04560231202124</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OC3 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.295Z</lastUpdated>
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    <udiDi>04560231202131</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OC4 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.281Z</lastUpdated>
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    <udiDi>04560231202148</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OD2 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.266Z</lastUpdated>
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    <udiDi>04560231202155</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OD3 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.251Z</lastUpdated>
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    <udiDi>04560231202162</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque OD4 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.232Z</lastUpdated>
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    <udiDi>04560231202179</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque Red Plus OA2 R 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.206Z</lastUpdated>
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    <udiDi>04560231202186</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque Red Plus OA3 R 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.182Z</lastUpdated>
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    <udiDi>04560231202193</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque Red Plus OA3.5 R 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.170Z</lastUpdated>
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    <udiDi>04560231202209</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque Special InO 1 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.152Z</lastUpdated>
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    <udiDi>04560231202216</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Opaque Special InO 2 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.126Z</lastUpdated>
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    <udiDi>04560231202223</udiDi>
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    <tradeName>TWiNY Opaque Special MO 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.106Z</lastUpdated>
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    <udiDi>04560231202230</udiDi>
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    <tradeName>TWiNY Gum Opaque OG1 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.085Z</lastUpdated>
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  <row>
    <udiDi>04560231202247</udiDi>
    <basicUdiDi>456023117D10B100N002U7</basicUdiDi>
    <tradeName>TWiNY Gum Opaque OG2 2.0ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>YAMAKIN CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000011382</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWiNY</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:56:45.061Z</lastUpdated>
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