<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05993220224767</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CX, 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>512381045100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305602</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381033140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975940</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA SI, Scanbody, szárnyas, L-forma, 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>521180042000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305619</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381038100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220224774</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CX, 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>512381045140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305626</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381038140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221351264</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA SI, Mintavételi fej, nyitott kanálhoz, multi-unit szintű, 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>521354050100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220224620</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CX, 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>512382018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220343543</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA SI, 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>521364033100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:23.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220224439</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CX, 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>512384018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305633</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381043100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305640</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381043140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220224613</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CX, 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>512385018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220343550</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA SI, 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>521364033140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305657</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381050100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220224422</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CX, 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>512387018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220343567</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA SI, 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>521364042100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305664</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381050140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220224415</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CX, 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>512388018000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220305671</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTILOG PCL, 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>519381060100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:18.338Z</lastUpdated>
  </row>
</eudamedExport>