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    <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>
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    <lastUpdated>2026-06-06T02:16:02.662Z</lastUpdated>
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    <tradeName>GUIDED DRILL-Q, 2.8 x 10mm</tradeName>
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    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <tradeName>GUIDED DRILL-Q, 2.8 x 8mm</tradeName>
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    <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>
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    <tradeName>GUIDED DRILL-Q, 2.8 x 6mm</tradeName>
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    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
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    <lastUpdated>2026-06-06T02:15:59.399Z</lastUpdated>
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    <udiDi>00810060221006</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>GUIDED DRILL-Q, 2.2 x 12mm</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:58.313Z</lastUpdated>
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    <udiDi>00810060220993</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>GUIDED DRILL-Q, 2.2 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00810060220986</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>GUIDED DRILL-Q, 2.2 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00810060220979</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>GUIDED DRILL-Q, 2.2 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:55.030Z</lastUpdated>
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    <udiDi>00810060220962</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.6 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:53.940Z</lastUpdated>
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    <udiDi>00810060220955</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.6 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:52.845Z</lastUpdated>
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    <udiDi>00810060220948</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.6 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:51.762Z</lastUpdated>
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    <udiDi>00810060220931</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.6 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:50.678Z</lastUpdated>
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    <udiDi>00810060220924</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.6 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:49.597Z</lastUpdated>
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    <udiDi>00810060220917</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.4 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:48.506Z</lastUpdated>
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    <udiDi>00810060220900</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.4 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>
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    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:47.414Z</lastUpdated>
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    <udiDi>00810060220894</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.4 x 10mm</tradeName>
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    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000014016</manufacturerSrn>
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    <emdnCode>Q010399</emdnCode>
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    <reference></reference>
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    <udiDi>00810060220887</udiDi>
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    <tradeName>Drill with Stop 4.4 x 8mm</tradeName>
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    <manufacturerName>Blue Sky Bio, LLC</manufacturerName>
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    <reference></reference>
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    <lastUpdated>2026-06-06T02:15:45.234Z</lastUpdated>
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    <udiDi>00810060220870</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 4.4 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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    <emdnCode>Q010399</emdnCode>
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    <reference></reference>
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    <lastUpdated>2026-06-06T02:15:44.106Z</lastUpdated>
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    <udiDi>00810060220863</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 3.9 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>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:43.015Z</lastUpdated>
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    <udiDi>00810060220856</udiDi>
    <basicUdiDi>081006022DRILLRUC1T4</basicUdiDi>
    <tradeName>Drill with Stop 3.9 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T02:15:41.935Z</lastUpdated>
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