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    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>Bio | Guide-Tube 6.35 OD x 5.35 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:16.774Z</lastUpdated>
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    <udiDi>00810060224045</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>Bio | Guide-Tube 6.25 OD x 5.25 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:15.669Z</lastUpdated>
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    <udiDi>00810060224038</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 6.2 OD x 5 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:14.564Z</lastUpdated>
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    <udiDi>00810060224021</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 6.2 OD x 5.31 ID x 4.5mm 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:13.463Z</lastUpdated>
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    <udiDi>00810060224014</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>Bio | Guide-Tube 6.15 OD x 5.15 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:12.375Z</lastUpdated>
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  <row>
    <udiDi>00810060224007</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 6.1 OD x 5.1 ID x 6mm 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:11.289Z</lastUpdated>
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    <udiDi>00810060223994</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube Nobel Master Wide 6.09 OD x 5.13 ID</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:10.197Z</lastUpdated>
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    <udiDi>00810060223987</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube Nobel Master Wide 6.09 OD x 4.73 ID</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:09.113Z</lastUpdated>
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    <udiDi>00810060223970</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube Nobel Master Wide 6.09 OD x 4.68 ID</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:08.031Z</lastUpdated>
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    <udiDi>00810060223963</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube Nobel Master Wide 6.09 OD x 4.27 ID</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:06.850Z</lastUpdated>
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  <row>
    <udiDi>00810060223949</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube for Cer. L 4.73mm</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:05.748Z</lastUpdated>
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  <row>
    <udiDi>00810060223932</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube for Cer. L 4.68mm</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:04.643Z</lastUpdated>
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  <row>
    <udiDi>00810060223925</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube for Cer. L 4.27mm</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:03.548Z</lastUpdated>
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    <udiDi>00810060223918</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube for Cer. L 3.71mm</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:02.462Z</lastUpdated>
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    <udiDi>00810060223901</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Guide-Tube for Cer. L 3.28mm</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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:01.382Z</lastUpdated>
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    <udiDi>00810060223895</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>Bio | Guide-Tube 5.7 OD x 4.7 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:13:00.301Z</lastUpdated>
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    <udiDi>00810060223888</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 5.57 OD x 4.52 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:12:59.223Z</lastUpdated>
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  <row>
    <udiDi>00810060223871</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 5.0 OD x 4.2 ID x 4.5mm 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:12:58.144Z</lastUpdated>
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    <udiDi>00810060223864</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 5.0 OD x 4.1 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:12:57.059Z</lastUpdated>
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    <udiDi>00810060223857</udiDi>
    <basicUdiDi>081006022TUBESU2F</basicUdiDi>
    <tradeName>BIO | Cut Guide Tube 5.0 OD x 3.9 ID x 5mm 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>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T03:12:55.966Z</lastUpdated>
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