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    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Max Implant Driver Handpiece RP Short</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>DMJHRS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.250Z</lastUpdated>
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    <udiDi>00815131029024</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Max Implant Driver Handpiece NP Short</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>DMJHS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.232Z</lastUpdated>
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    <udiDi>00815131029031</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | One Stage Hand Piece Implant Driver Long</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>DML</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.210Z</lastUpdated>
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    <udiDi>00815131029048</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Quattro Handpiece Implant Driver Long 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>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMLQN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.187Z</lastUpdated>
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    <udiDi>00815131029055</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Quattro Handpiece Implant Driver Long 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>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMLQR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.162Z</lastUpdated>
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  <row>
    <udiDi>00815131029062</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | One Stage Hand Piece Implant Driver Short</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>DMS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.137Z</lastUpdated>
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  <row>
    <udiDi>00815131029079</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Internal Hex Implant Driver Handpiece Long</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>DMSBLIH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.111Z</lastUpdated>
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  <row>
    <udiDi>00815131029086</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Internal Hex Implant Driver Handpiece Short</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>DMSBSIH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.087Z</lastUpdated>
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  <row>
    <udiDi>00815131029093</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Quattro Handpiece Implant Driver Short 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>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMSQN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.060Z</lastUpdated>
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  <row>
    <udiDi>00815131029109</udiDi>
    <basicUdiDi>081513102DRIVERRUC1QT</basicUdiDi>
    <tradeName>BIO | Quattro Handpiece Implant Driver Short 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>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMSQR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.031Z</lastUpdated>
  </row>
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    <udiDi>00815131029116</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 2.0 x 6mm</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:49.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131029123</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 2.0 x 8mm</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.982Z</lastUpdated>
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  <row>
    <udiDi>00815131029130</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 2.0 x 10mm</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131029147</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 2.0 x 11.5mm</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>00815131029154</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 2.0 x 13mm</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.911Z</lastUpdated>
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  <row>
    <udiDi>00815131029161</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 2.5 x 6mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2506</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.889Z</lastUpdated>
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  <row>
    <udiDi>00815131029178</udiDi>
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    <tradeName>Guided Drill 2.5 x 8mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2508</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.865Z</lastUpdated>
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  <row>
    <udiDi>00815131029192</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 2.5 x 11.5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2511</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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  <row>
    <udiDi>00815131029208</udiDi>
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    <tradeName>Guided Drill 2.5 x 13mm</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG2513</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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  <row>
    <udiDi>00815131029215</udiDi>
    <basicUdiDi>081513102DRILLRUC1X6</basicUdiDi>
    <tradeName>Guided Drill 3.0 x 6mm</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 IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRILG3006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:36:48.796Z</lastUpdated>
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