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<eudamedExport entity="devices">
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    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z497 201 945 3104 010、Z497 201 945 3105 015、Z497 201 945 3106 020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:53.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200916887</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z497 201 945 2104 010、Z497 201 945 2105 015、Z497 201 945 2106 020、Z497 201 945 2106 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:53.132Z</lastUpdated>
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    <udiDi>06942200916894</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z497 201 945 2104 010、Z497 201 945 2105 015、Z497 201 945 2106 020、Z497 201 945 2106 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:53.112Z</lastUpdated>
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  <row>
    <udiDi>06942200916900</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z497 201 945 2504 010、Z497 201 945 2505 015、Z497 201 945 2506 020、Z497 201 945 2506 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:53.028Z</lastUpdated>
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    <udiDi>06942200916917</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z497 201 945 2504 010、Z497 201 945 2505 015、Z497 201 945 2506 020、Z497 201 945 2506 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:52.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200916924</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z497 201 945 3104 010、Z497 201 945 3105 015、Z497 201 945 3106 020、Z497 201 945 3106 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:52.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200916931</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z497 201 945 3104 010、Z497 201 945 3105 015、Z497 201 945 3106 020、Z497 201 945 3106 025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:52.825Z</lastUpdated>
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  <row>
    <udiDi>06942200916948</udiDi>
    <basicUdiDi>697590932NiTiRotary96</basicUdiDi>
    <tradeName>MT Gold</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z4972019452105015、Z4972019452106020、Z4972019452106025、Z4972019452106030、Z4972019452106035、Z4972019452106040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:53:52.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050996110964</udiDi>
    <basicUdiDi>8050996STRCANMNSTV7</basicUdiDi>
    <tradeName>Dabliu file H-Files SS</tradeName>
    <deviceName>PERNI ENDOCANALARI MANUALI STERILI</deviceName>
    <manufacturerName>DENTAL WORLD S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000019581</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>144515422S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:34:35.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050996027958</udiDi>
    <basicUdiDi>8050996STRCANMEC3G</basicUdiDi>
    <tradeName>Dabliu file Gates drills</tradeName>
    <deviceName>PERNI ENDOCANALARI MECCANICI NON STERILI</deviceName>
    <manufacturerName>DENTAL WORLD S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000019581</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>144910004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:34:34.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>08050996111923</udiDi>
    <basicUdiDi>8050996STRCANMCSTTG</basicUdiDi>
    <tradeName>Dabliu file Gates drills</tradeName>
    <deviceName>PERNI ENDOCANALARI STERILI MECCANICI</deviceName>
    <manufacturerName>DENTAL WORLD S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000019581</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>144910004S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:34:32.736Z</lastUpdated>
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  <row>
    <udiDi>08050996024445</udiDi>
    <basicUdiDi>8050996STRCANMAN3S</basicUdiDi>
    <tradeName>H-Files Ni-Ti</tradeName>
    <deviceName>PERNI ENDOCANALARI MANUALI NON STERILI</deviceName>
    <manufacturerName>DENTAL WORLD S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000019581</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>144442803</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-04T19:34:15.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200417</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,30/.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200424</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,35/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200431</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,35/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200448</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,40/.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200455</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,40/.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200462</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,40/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200479</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,40/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>06959074200523</udiDi>
    <basicUdiDi>69590742NiTiRotaryVR</basicUdiDi>
    <tradeName>Dental Root-Canal Instruments</tradeName>
    <deviceName>Dental Root-Canal Instruments</deviceName>
    <manufacturerName>Shenzhen Perfect Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025529</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EX-GOLD,15/.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T21:59:17.324Z</lastUpdated>
  </row>
</eudamedExport>