<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05993220305527</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, Mintavételi fej, nyitott kanálhoz, uniform, nem pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>519364038140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:28.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220146922</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA ECOPLANT, Mintavételi fej, zárt kanálhoz, uniform, pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504381035140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:28.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220206770</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody fej, átmenőcsavaros, pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510496060120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:28.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305534</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, Mintavételi fej, nyitott kanálhoz, uniform, nem pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>519364043100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:28.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220206787</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody fej, átmenőcsavaros, pozicionált, keskeny</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510497035100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220146755</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA ECOPLANT, Mintavételi fejcsavar, nyitott kanálhoz, hosszú</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504382018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305541</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, Mintavételi fej, nyitott kanálhoz, uniform, nem pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>519364043140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220146564</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA ECOPLANT, Mintavételi fejcsavar, nyitott kanálhoz, rövid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504384018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220206794</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody fej, átmenőcsavaros, pozicionált, keskeny</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510497043100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305558</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, Mintavételi fej, nyitott kanálhoz, uniform, nem pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>519364050100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220146748</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA ECOPLANT, Mintavételi fejcsavar, zárt kanálhoz, hosszú</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504385018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220206800</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody fej, átmenőcsavaros, pozicionált, keskeny</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510497050100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305565</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, Mintavételi fej, nyitott kanálhoz, uniform, nem pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>519364050140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220146557</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA ECOPLANT, Mintavételi fejcsavar, zárt kanálhoz, parallel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504387018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220206817</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody fej, átmenőcsavaros, pozicionált, keskeny</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510497060100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305572</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, Mintavételi fej, nyitott kanálhoz, uniform, nem pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>519364060100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220146540</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA ECOPLANT, Mintavételi fejcsavar, zárt kanálhoz, rövid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504388018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220215345</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody keskeny, átmenőcsavar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>510605018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305589</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, Mintavételi fej, nyitott kanálhoz, uniform, nem pozicionált</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>519364060140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220142993</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA ECOPLANT, Multifunkciós fej</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIONIKA Medline Kft.</manufacturerName>
    <manufacturerSrn>HU-MF-000004631</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010207</emdnCode>
    <emdnDescription>DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504394035000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:27.596Z</lastUpdated>
  </row>
</eudamedExport>