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    <tradeName>Premier Elevator</tradeName>
    <deviceName>ELEVATOR CAMERON</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1003371</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:52:56.286Z</lastUpdated>
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    <udiDi>00348783004090</udiDi>
    <basicUdiDi>B-00348783004090</basicUdiDi>
    <tradeName>Premier Elevator</tradeName>
    <deviceName>ELEVATOR SELDIN 4R</deviceName>
    <manufacturerName>Premier Dental Products Company</manufacturerName>
    <manufacturerSrn>US-MF-000015778</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1003369</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T06:52:55.497Z</lastUpdated>
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    <udiDi>*+D99480500104*</udiDi>
    <basicUdiDi>B-*+D99480500104*</basicUdiDi>
    <tradeName>COUNTERSINK DRILL 3.3 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.868Z</lastUpdated>
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    <udiDi>*+D99480500205*</udiDi>
    <basicUdiDi>B-*+D99480500205*</basicUdiDi>
    <tradeName>COUNTERSINK DRILL 4.1 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805002</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480500306*</udiDi>
    <basicUdiDi>B-*+D99480500306*</basicUdiDi>
    <tradeName>COUNTERSINK DRILL 5.0 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805003</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480500407*</udiDi>
    <basicUdiDi>B-*+D99480500407*</basicUdiDi>
    <tradeName>Lance Drill 2.0</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805004</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480500508*</udiDi>
    <basicUdiDi>B-*+D99480500508*</basicUdiDi>
    <tradeName>Helical Drill 2.0 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805005</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480500609*</udiDi>
    <basicUdiDi>B-*+D99480500609*</basicUdiDi>
    <tradeName>Helical Drill 2.8 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805006</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050070A*</udiDi>
    <basicUdiDi>B-*+D9948050070A*</basicUdiDi>
    <tradeName>Helical Drill 3.0 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805007</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050080B*</udiDi>
    <basicUdiDi>B-*+D9948050080B*</basicUdiDi>
    <tradeName>Helical Drill 3.15 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805008</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050090C*</udiDi>
    <basicUdiDi>B-*+D9948050090C*</basicUdiDi>
    <tradeName>Helical Drill 3.3 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805009</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480501004*</udiDi>
    <basicUdiDi>B-*+D99480501004*</basicUdiDi>
    <tradeName>Helical Drill 3.8 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805010</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480501105*</udiDi>
    <basicUdiDi>B-*+D99480501105*</basicUdiDi>
    <tradeName>Helical Drill 4.3 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805011</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480501206*</udiDi>
    <basicUdiDi>B-*+D99480501206*</basicUdiDi>
    <tradeName>Helical Drill 4.5 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805012</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480501307*</udiDi>
    <basicUdiDi>B-*+D99480501307*</basicUdiDi>
    <tradeName>Pilot Drill 2/3</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805013</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480501408*</udiDi>
    <basicUdiDi>B-*+D99480501408*</basicUdiDi>
    <tradeName>Pilot Drill 3/4</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805014</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480501509*</udiDi>
    <basicUdiDi>B-*+D99480501509*</basicUdiDi>
    <tradeName>Drill for Conical Implant 4.0 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805015</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050160A*</udiDi>
    <basicUdiDi>B-*+D9948050160A*</basicUdiDi>
    <tradeName>Drill for Conical Implant 5.0 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805016</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050170B*</udiDi>
    <basicUdiDi>B-*+D9948050170B*</basicUdiDi>
    <tradeName>Drill for Contra-Angle 1.1 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805017</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050180C*</udiDi>
    <basicUdiDi>B-*+D9948050180C*</basicUdiDi>
    <tradeName>Straight Handpiece Drill 1.1 MM</tradeName>
    <deviceName>DRILL's</deviceName>
    <manufacturerName>SYSTHEX SISTEMAS DE IMPLANTES ÓSSEO INTEGRADO LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000043219</manufacturerSrn>
    <authorisedRepresentativeName>SBP PORTUGAL LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000042998</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>805018</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.427Z</lastUpdated>
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