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<eudamedExport entity="devices">
  <row>
    <udiDi>00810060223956</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide Tube for Cer. L 5.04mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUBE59-504-45L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:49:11.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810060224847</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 5.8 OD x 4.8 ID x 4mm L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUBE58-48-4L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T03:49:10.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028270</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>Screw Remover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFSR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028300</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Narrow 4mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAN4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028317</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Narrow  5.5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAN5500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028324</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Narrow 7mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAN7000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028331</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Regular 4mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAR4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028348</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Regular 5.5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAR5500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028355</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Regular 7mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAR7000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028362</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Wide 4mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAW4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028379</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Wide 5.5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAW5500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028386</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog BIO | Conus 12 / 3.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDH30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028393</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog BIO | Conus 12 Implant Level 3.5/4.0 Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDH35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028409</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>BIO | Conus Implant Analog 4.5/5.0 Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BDH50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028416</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Level Internal Hex 3.5mm Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIH35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028430</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Analog Level Internal Hex 4.5mm Platform</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIH45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028447</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>BIO | Max Implant Analog NP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIJH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028454</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>BIO | Max Implant Analog RP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BIJHR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028461</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>Implant Analog BIO | Quattro Narrow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BISQN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131028478</udiDi>
    <basicUdiDi>081513102ANALOGSUC19N</basicUdiDi>
    <tradeName>BIO | Quattro Implant Analog RP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BISQR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:50.014Z</lastUpdated>
  </row>
</eudamedExport>