<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800049387825</udiDi>
    <basicUdiDi>880004926038BW</basicUdiDi>
    <tradeName>Straight Drill</tradeName>
    <deviceName>Straight Drill, Position Drill</deviceName>
    <manufacturerName>DIO Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008515</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIO Implant System Product Catalog Ver 7.0 (KR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:26.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800049306352</udiDi>
    <basicUdiDi>880004925041BC</basicUdiDi>
    <tradeName>DIO Fixture Driver assy (Machine)</tradeName>
    <deviceName>DIO Drill Extension Cover SET, UF(II) Profile Drill, DIO Fixture Driver assy (Machine), DIO Surgical Kit, DIO Straight Dril, DIO Master Kit</deviceName>
    <manufacturerName>DIO Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008515</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIO Implant System Product Catalog Ver 7.0 (KR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:26.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800049286470</udiDi>
    <basicUdiDi>880004921004AA</basicUdiDi>
    <tradeName>DIO Multi Unit Abutment Holder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIO Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008515</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAH 1425</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:25.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800049210017</udiDi>
    <basicUdiDi>880004925044BJ</basicUdiDi>
    <tradeName>Protem Sugical Kit</tradeName>
    <deviceName>DIO Bone Expander, DIO Mount Driver, Protem Sugical Kit</deviceName>
    <manufacturerName>DIO Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008515</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIO Implant System Product Catalog Ver 7.0 (KR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:24.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800049206805</udiDi>
    <basicUdiDi>880004925042BE</basicUdiDi>
    <tradeName>DIOnavi. Bone Flattening Drill</tradeName>
    <deviceName>DIO Straight Drill, UF(II) Wide Surgical Kit, DIOnavi. Straight Drill, DIOnavi. Bone Flattening Drill, DIO Flapless Crestal Sinus kit, DIOnavi. Special Kit, DIOnavi. Anchor Drill</deviceName>
    <manufacturerName>DIO Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008515</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIO Implant System Product Catalog Ver 7.0 (KR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:20.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800049206553</udiDi>
    <basicUdiDi>880004925043BG</basicUdiDi>
    <tradeName>DIOnavi. Abutment Profile Drill</tradeName>
    <deviceName>DIO Master S Kit, DIOnavi. Profile Drill, UF(II) Guide Side Cut Drill, DIOnavi. Initial Positioning Dril, Deep Bone Flattening Drill, UF(II) Narrow Surgical Kit, DIOnavi. Straight Drill, DIO New Dr. SOS+ Kit, UF(II) Starter Kit, and 1 additional item</deviceName>
    <manufacturerName>DIO Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008515</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020180</emdnCode>
    <emdnDescription>DENTAL IMPLANTS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIO Implant System Product Catalog Ver 7.0 (KR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:19.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800049202883</udiDi>
    <basicUdiDi>880004921003A8</basicUdiDi>
    <tradeName>DIO Square Adapter</tradeName>
    <deviceName>UniCon Abutment Protect Cap, UniCon Abutment Impression Cap, UniCon Pick up Impression Coping, UniCon Transfer Impression Coping, UniCon Abutment Lab Analog, FTN Fixture Driver, Initial Check Pin, Fixture Driver, and 39 additional item</deviceName>
    <manufacturerName>DIO Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000008515</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010399</emdnCode>
    <emdnDescription>SURGICAL DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIO Implant System Product Catalog Ver 7.0 (KR)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:18.855Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342748</udiDi>
    <basicUdiDi>B-08717973342748</basicUdiDi>
    <tradeName>ERBB2 (17q12)/SE 17</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10701</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342762</udiDi>
    <basicUdiDi>B-08717973342762</basicUdiDi>
    <tradeName>IGH (14q32) Break (tissue)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10729</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342823</udiDi>
    <basicUdiDi>B-08717973342823</basicUdiDi>
    <tradeName>MDM2 (12q15)/SE 12</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10717</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342854</udiDi>
    <basicUdiDi>B-08717973342854</basicUdiDi>
    <tradeName>BCL6 (3q27) Break (tissue)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10730</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342885</udiDi>
    <basicUdiDi>B-08717973342885</basicUdiDi>
    <tradeName>SS18 (18q11) Break</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10713</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342892</udiDi>
    <basicUdiDi>B-08717973342892</basicUdiDi>
    <tradeName>DDIT3 (12q13 Break</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10714</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342908</udiDi>
    <basicUdiDi>B-08717973342908</basicUdiDi>
    <tradeName>FUS (16p11) Break</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10715</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973342915</udiDi>
    <basicUdiDi>B-08717973342915</basicUdiDi>
    <tradeName>FOXO1 (13q14) Break</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10716</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973343981</udiDi>
    <basicUdiDi>B-08717973343981</basicUdiDi>
    <tradeName>MET (7q31)/SE 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-10719</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973347484</udiDi>
    <basicUdiDi>871797334PTKTD200007CE</basicUdiDi>
    <tradeName>Tissue Digestion Kit II</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-60004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973347491</udiDi>
    <basicUdiDi>871797334PTKFRG00007KN</basicUdiDi>
    <tradeName>FISH Reagent Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-60005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973347507</udiDi>
    <basicUdiDi>871797334PTKFDG00007C8</basicUdiDi>
    <tradeName>FISH Digestion Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-60006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717973347545</udiDi>
    <basicUdiDi>871797334PTKTD100007BZ</basicUdiDi>
    <tradeName>Tissue Digestion Kit I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Newcastle Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000020595</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA IN SITU HYBRIDISATION REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-60007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:44.545Z</lastUpdated>
  </row>
</eudamedExport>