<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06260319648537</udiDi>
    <basicUdiDi>62603196EDGE-FILEQF</basicUdiDi>
    <tradeName>Hamerz Medical / EDGE</tradeName>
    <deviceName>Rotary File</deviceName>
    <manufacturerName>Hamerz Medical CO.</manufacturerName>
    <manufacturerSrn>IR-MF-000052221</manufacturerSrn>
    <authorisedRepresentativeName>Source of Commerce GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050360</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010507</emdnCode>
    <emdnDescription>ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFUFILE23V02</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:33:06.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06260001798472</udiDi>
    <basicUdiDi>62600017EDGE-FLOWEG</basicUdiDi>
    <tradeName>EDGE</tradeName>
    <deviceName>Universal Composite</deviceName>
    <manufacturerName>Hamerz Medical CO.</manufacturerName>
    <manufacturerSrn>IR-MF-000052221</manufacturerSrn>
    <authorisedRepresentativeName>Source of Commerce GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050360</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFUCOM23V01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:33:04.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06260001798465</udiDi>
    <basicUdiDi>62600017EDGE-COM4U</basicUdiDi>
    <tradeName>EDGE</tradeName>
    <deviceName>Universal Composite</deviceName>
    <manufacturerName>Hamerz Medical CO.</manufacturerName>
    <manufacturerSrn>IR-MF-000052221</manufacturerSrn>
    <authorisedRepresentativeName>Source of Commerce GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000050360</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFUCOM23V01</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:33:03.845Z</lastUpdated>
  </row>
</eudamedExport>