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    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050306</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
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    <reference>TW-T010</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:08:16.314Z</lastUpdated>
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    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <deviceName></deviceName>
    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
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    <lastUpdated>2026-06-24T23:08:13.919Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TW-T007</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:08:12.704Z</lastUpdated>
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    <udiDi>06939797200062</udiDi>
    <basicUdiDi>69397972MG001VN</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050306</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TW-T006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:08:11.505Z</lastUpdated>
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    <udiDi>06939797200055</udiDi>
    <basicUdiDi>69397972MG001VN</basicUdiDi>
    <tradeName>06939797200055</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050306</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TW-T005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:08:10.297Z</lastUpdated>
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    <udiDi>06939797200048</udiDi>
    <basicUdiDi>69397972MG001VN</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050306</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TW-T004</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:08:09.097Z</lastUpdated>
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    <udiDi>06939797200031</udiDi>
    <basicUdiDi>69397972MG001VN</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050306</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TW-T003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:08:07.898Z</lastUpdated>
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    <udiDi>06939797200024</udiDi>
    <basicUdiDi>69397972MG001VN</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Fuzhou Delphin Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050306</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TW-T002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:08:06.724Z</lastUpdated>
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    <udiDi>08800003010028</udiDi>
    <basicUdiDi>88000030RDT00174</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Ray Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007225</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBS-DT01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:49.489Z</lastUpdated>
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    <udiDi>08800003010035</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Ray Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007225</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBS-DT01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:49.474Z</lastUpdated>
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    <udiDi>08800003010042</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Ray Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBS-DT01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:49.459Z</lastUpdated>
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    <udiDi>08800003010059</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Ray Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007225</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBS-DT01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:46.519Z</lastUpdated>
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    <udiDi>08800003010066</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Ray Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000007225</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBS-DT01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:46.509Z</lastUpdated>
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    <udiDi>08800003010073</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Ray Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>Q010503</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RBS-DT01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:46.492Z</lastUpdated>
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    <manufacturerName>Ray Co., Ltd.</manufacturerName>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:46.478Z</lastUpdated>
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    <udiDi>08800003010097</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Ray Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:46.466Z</lastUpdated>
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    <udiDi>00816063020356</udiDi>
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    <tradeName>Invisalign Impression Tray, Plastic, Upper, X-Large</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
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    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2563</reference>
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    <lastUpdated>2026-06-23T20:46:50.322Z</lastUpdated>
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    <udiDi>00816063020363</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
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    <manufacturerName>Align Technology Inc.</manufacturerName>
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    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2564</reference>
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    <lastUpdated>2026-06-23T20:46:50.305Z</lastUpdated>
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    <udiDi>00816063020370</udiDi>
    <basicUdiDi>081606302ImpTrayCC</basicUdiDi>
    <tradeName>Invisalign Impression Tray, Plastic, Upper, Medium</tradeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2565</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:46:50.290Z</lastUpdated>
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