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<eudamedExport entity="devices">
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    <udiDi>*+D9948050350B*</udiDi>
    <basicUdiDi>B-*+D9948050350B*</basicUdiDi>
    <tradeName>COUNTERSINK DRILL 4.1 GUIDE</tradeName>
    <deviceName>DRLL'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>805035</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050360C*</udiDi>
    <basicUdiDi>B-*+D9948050360C*</basicUdiDi>
    <tradeName>Tapered Drill  3,5mm GUIDE</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>805036</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.108Z</lastUpdated>
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  <row>
    <udiDi>*+D9948050380E*</udiDi>
    <basicUdiDi>B-*+D9948050380E*</basicUdiDi>
    <tradeName>Helical Drill 4.3 GUIDE</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>805038</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050390F*</udiDi>
    <basicUdiDi>B-*+D9948050390F*</basicUdiDi>
    <tradeName>Tapered Drill  3,5mm for Dense Bone</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>805039</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480504007*</udiDi>
    <basicUdiDi>B-*+D99480504007*</basicUdiDi>
    <tradeName>Tapered Drill for Dense Bone 4,3mm Guide</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>805040</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D99480504108*</udiDi>
    <basicUdiDi>B-*+D99480504108*</basicUdiDi>
    <tradeName>Drill for Fixation Pin GUIDE</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>805041</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:27.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050640D*</udiDi>
    <basicUdiDi>B-*+D9948050640D*</basicUdiDi>
    <tradeName>Tapered Drill for Dense Bone 3.5</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>805064</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050650E*</udiDi>
    <basicUdiDi>B-*+D9948050650E*</basicUdiDi>
    <tradeName>Tapered Drill for Dense Bone 4,3mm</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>805065</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050670G*</udiDi>
    <basicUdiDi>B-*+D9948050670G*</basicUdiDi>
    <tradeName>Lance Helical Drill  Ø2,0mm with Stop</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>805067</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050680H*</udiDi>
    <basicUdiDi>B-*+D9948050680H*</basicUdiDi>
    <tradeName>Tapered Drill  3,5mm  with Stop</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>805068</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050690I*</udiDi>
    <basicUdiDi>B-*+D9948050690I*</basicUdiDi>
    <tradeName>Tapered Drill  4,0mm  with Stop</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>805069</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050700A*</udiDi>
    <basicUdiDi>B-*+D9948050700A*</basicUdiDi>
    <tradeName>Tapered Drill  4,3mm  with Stop</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>805070</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050710B*</udiDi>
    <basicUdiDi>B-*+D9948050710B*</basicUdiDi>
    <tradeName>Tapered Drill  5,0mm  with Stop</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>805071</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050730D*</udiDi>
    <basicUdiDi>B-*+D9948050730D*</basicUdiDi>
    <tradeName>Tapered Drill  4,3mm for Dense Bone with Stop</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>805073</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050740E*</udiDi>
    <basicUdiDi>B-*+D9948050740E*</basicUdiDi>
    <tradeName>Helical Drill  2,0mm with Stop</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>805074</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050750F*</udiDi>
    <basicUdiDi>B-*+D9948050750F*</basicUdiDi>
    <tradeName>Helical Drill  2,8mm with Stop</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>805075</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050760G*</udiDi>
    <basicUdiDi>B-*+D9948050760G*</basicUdiDi>
    <tradeName>Helical Drill  3,0mm with Stop</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>805076</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050770H*</udiDi>
    <basicUdiDi>B-*+D9948050770H*</basicUdiDi>
    <tradeName>Helical Drill  3,15mm with Stop</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>805077</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050780I*</udiDi>
    <basicUdiDi>B-*+D9948050780I*</basicUdiDi>
    <tradeName>Helical Drill  3,3mm with Stop</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>805078</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+D9948050790J*</udiDi>
    <basicUdiDi>B-*+D9948050790J*</basicUdiDi>
    <tradeName>Helical Drill  3,8mm with Stop</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>805079</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-01T02:27:26.637Z</lastUpdated>
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