<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08059493782698</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE-BOX</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:51:43.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059493782773</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>MDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1807BOX.</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:51:43.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059493780595</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-00093SC/S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:50:27.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053847156944</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00075SC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:50:27.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>08059493780250</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3P-00099SC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:50:27.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053847158535</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00098SC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:50:27.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053847157545</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WIDE-00092SC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:50:27.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055728023109</udiDi>
    <basicUdiDi>B-08055728023109</basicUdiDi>
    <tradeName>PRIMER KIT CHIRURGICO - MANUALE</tradeName>
    <deviceName>KIT CHIRURGICO / SURGICAL KIT</deviceName>
    <manufacturerName>Edierre Implant System Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027663</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P700000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:15:33.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055728022676</udiDi>
    <basicUdiDi>B-08055728022676</basicUdiDi>
    <tradeName>PRIMER KIT CHIRURGICO</tradeName>
    <deviceName>KIT CHIRURGICO COMPLETO /  COMPLETE SURGICAL KIT</deviceName>
    <manufacturerName>Edierre Implant System Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000027663</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P500000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:12:25.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995299925</udiDi>
    <basicUdiDi>999520000076KF</basicUdiDi>
    <tradeName>KIT SURGICAL GUIDED UNITITE</tradeName>
    <deviceName>KIT SURGICAL GUIDED UNITITE</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCSUG 02</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:42.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995299901</udiDi>
    <basicUdiDi>999520000075KD</basicUdiDi>
    <tradeName>KIT SURGICAL GUIDED STRONG SW</tradeName>
    <deviceName>KIT SURGICAL GUIDED STRONG SW</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCSWG 02</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:41.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995293565</udiDi>
    <basicUdiDi>999520000062K4</basicUdiDi>
    <tradeName>KIT SURGICAL TRYON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCHE 04</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:36.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995274670</udiDi>
    <basicUdiDi>999520000077KH</basicUdiDi>
    <tradeName>KIT SURGICAL GUIDED EPIKUT</tradeName>
    <deviceName>KIT SURGICAL GUIDED EPIKUT</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCSEG 01I</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:35.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995270276</udiDi>
    <basicUdiDi>999520000083KC</basicUdiDi>
    <tradeName>KIT REPLACEMENT DRILL STRONG SW</tradeName>
    <deviceName>KIT REPLACEMENT DRILL STRONG SW</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRFSW</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:34.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995270269</udiDi>
    <basicUdiDi>999520000080K6</basicUdiDi>
    <tradeName>KIT REPLACEMENT DRILL TRYON</tradeName>
    <deviceName>KIT REPLACEMENT DRILL TRYON or KIT REPLACEMENT DRILL TRYON CONICAL</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRFT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:32.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995258854</udiDi>
    <basicUdiDi>999520000072K7</basicUdiDi>
    <tradeName>KIT SURGICAL EPIKUT</tradeName>
    <deviceName>KIT SURGICAL EPIKUT or SURGICAL KIT EPIKUT LONG</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCSE 01</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:27.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995216724</udiDi>
    <basicUdiDi>999520000081K8</basicUdiDi>
    <tradeName>KIT REPLACEMENT DRILL UNITITE</tradeName>
    <deviceName>KIT REPLACEMENT DRILL UNITITE</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRFU</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:25.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995216182</udiDi>
    <basicUdiDi>999520000079KM</basicUdiDi>
    <tradeName>KIT REPLACEMENT DRILL TRYON</tradeName>
    <deviceName>KIT SHORT DRILL UNITITE</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRFT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:23.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995209450</udiDi>
    <basicUdiDi>999520000078KK</basicUdiDi>
    <tradeName>KIT SHORT DRILL STRONG SW</tradeName>
    <deviceName>KIT SHORT DRILL STRONG SW</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KSDSW</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:14.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>07899995209368</udiDi>
    <basicUdiDi>999520000036K3</basicUdiDi>
    <tradeName>KIT EXPANDER</tradeName>
    <deviceName>KIT (with exparder, Osteotome or Curette)</deviceName>
    <manufacturerName>S.I.N. Implant System Ltda.</manufacturerName>
    <manufacturerSrn>BR-MF-000019848</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KEXP</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:26:12.754Z</lastUpdated>
  </row>
</eudamedExport>