<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05993220207616</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Harapásvételi fej, becsavarható, implant szintű</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>510162060040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220207623</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Harapásvételi fej, becsavarható, implant szintű</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>510162060060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220115591</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, 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>502605020000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975230</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, T-forma</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>510178035000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221201675</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, nyitott kanálhoz, multi-unit szintű, 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>502794047100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975247</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, T-forma</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>510178043000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221192508</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, nyitott kanálhoz, multi-unit szintű, pozicionált, széles</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>502795100000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975254</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, T-forma</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>510178050000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221201682</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, nyitott kanálhoz, multi-unit szintű, nem 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>502796047100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221192027</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, nyitott kanálhoz, multi-unit szintű, nem pozicionált, széles</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>502797100000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975261</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, T-forma</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>510178060000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221201651</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, zárt kanálhoz, multi-unit szintű, nem 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>502798047100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:39.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975193</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, L-forma, 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>510179035000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221192041</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, zárt kanálhoz, multi-unit szintű, nem pozicionált, széles</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>502799100000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975209</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, L-forma, 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>510179043000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.831Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221201668</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, zárt kanálhoz, multi-unit szintű, 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>502800047100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975216</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, L-forma, 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>510179050000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993221192522</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA BIOPLANT, Mintavételi fej, zárt kanálhoz, multi-unit szintű, pozicionált, széles</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>502801100000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993222975223</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA RP, Scanbody, szárnyas, L-forma, 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>510179060000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>05993220132932</udiDi>
    <basicUdiDi>599322000ST</basicUdiDi>
    <tradeName>BIONIKA CORTICAL, Harapásvételi fej, becsavarható, implant szintű</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>503162030005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:06:38.422Z</lastUpdated>
  </row>
</eudamedExport>