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    <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>SSK,#06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:17:08.245Z</lastUpdated>
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    <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>SSK,#15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:17:07.042Z</lastUpdated>
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    <basicUdiDi>69590742HandfilesPT</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>SSK,#10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:17:04.650Z</lastUpdated>
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    <basicUdiDi>69590742HandfilesPT</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>SSK,#08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:17:01.049Z</lastUpdated>
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    <udiDi>06959074296908</udiDi>
    <basicUdiDi>69590742HandfilesPT</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>SSK,#20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:58.631Z</lastUpdated>
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  <row>
    <udiDi>06959074296892</udiDi>
    <basicUdiDi>69590742HandfilesPT</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>SSK,#45、#50、#55、#60、#70、#80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:57.448Z</lastUpdated>
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    <udiDi>06959074296885</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>机用MTF,40/.06、50/.05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:55.040Z</lastUpdated>
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    <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>i File X GOLD,15/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:51.429Z</lastUpdated>
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    <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>i File X GOLD,15/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:49.027Z</lastUpdated>
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    <udiDi>06959074296854</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>i File X GOLD,15/.04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:47.822Z</lastUpdated>
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    <udiDi>06959074296847</udiDi>
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    <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>MT GOLD(21mm系),40/.06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:45.426Z</lastUpdated>
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    <udiDi>06959074296830</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>RT,25/.08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:41.821Z</lastUpdated>
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    <udiDi>06959074296823</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>RT,30/.09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:39.428Z</lastUpdated>
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    <udiDi>06959074296816</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>RT,20/.07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:38.221Z</lastUpdated>
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    <udiDi>06959074296809</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>UT-GOLD,17/.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:35.815Z</lastUpdated>
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    <udiDi>06959074296793</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>PX WAVE GOLD,15/.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:32.218Z</lastUpdated>
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    <udiDi>06959074296786</udiDi>
    <basicUdiDi>69590742NiTiCompactorMW</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>SSS,#15、#20、#25、#30、#35、#40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:29.811Z</lastUpdated>
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    <udiDi>06959074296779</udiDi>
    <basicUdiDi>69590742NiTiCompactorMW</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>SSS,#15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:28.611Z</lastUpdated>
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    <basicUdiDi>69590742NiTiCompactorMW</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>SSS,#25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:26.206Z</lastUpdated>
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    <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>机用MTF,19/.04、18/.02、20/.04、20/.07、25/.08、30/.09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:16:22.608Z</lastUpdated>
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