<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08055186670822</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>OMNISCOP DReam</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 09 000-3; 74 11 000-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:40.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671157</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>Arcovis DRF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 10 000-3; 74 12 000-3; 74 14 000; 74 15 000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:12.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671133</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>Arcovis DRF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 10 000-2; 74 12 000-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:11.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671126</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>Arcovis DRF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 10 000-1; 74 12 000-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:11.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671140</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>Arcovis DRF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 09 000-3; 74 11 000-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:11.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671119</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>Arcovis DRF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 09 000-2; 74 11 000-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:11.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186671102</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>Arcovis DRF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 09 000-1; 74 11 000-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:10.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186670945</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>CARMEX RK FP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 09 000-3; 74 11 000-3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:10.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>08055186670952</udiDi>
    <basicUdiDi>805518667FPVP</basicUdiDi>
    <tradeName>CARMEX RK FP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>A.T.S. Applicazione Tecnologie Speciali s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000010734</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z11039017</emdnCode>
    <emdnDescription>MOBILE RADIOSCOPIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>74 10 000-3; 74 12 000-3; 74 14 000; 74 15 000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:09.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>10841716103909</udiDi>
    <basicUdiDi>08417161000016G2</basicUdiDi>
    <tradeName>ACIST Pro Small Bed Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACIST Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010784</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11039085</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>019257</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:08.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CH-MF-000019387KE</udiDi>
    <basicUdiDi>B-CH-MF-000019387KE</basicUdiDi>
    <tradeName>CT Expres Evo</tradeName>
    <deviceName>CT Expres Evo</deviceName>
    <manufacturerName>Bracco Injeneering SA</manufacturerName>
    <manufacturerSrn>CH-MF-000019387</manufacturerSrn>
    <authorisedRepresentativeName>ACIST Europe BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002151</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039014</emdnCode>
    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650600</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-13T01:04:00.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CAASA-Valve2.04R</udiDi>
    <basicUdiDi>B-CAASA-Valve2.04R</basicUdiDi>
    <tradeName>CAAS A-Valve</tradeName>
    <deviceName>CAAS A-Valve 2.0</deviceName>
    <manufacturerName>Pie Medical Imaging B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:20.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CAASA-Valve1.14N</udiDi>
    <basicUdiDi>B-CAASA-Valve1.14N</basicUdiDi>
    <tradeName>CAAS A-Valve</tradeName>
    <deviceName>CAAS A-Valve 1.1</deviceName>
    <manufacturerName>Pie Medical Imaging B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001540</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:19.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>B826CINACHEST10</udiDi>
    <basicUdiDi>B-B826CINACHEST10</basicUdiDi>
    <tradeName>CINA-CHEST</tradeName>
    <deviceName>CINA-CHEST</deviceName>
    <manufacturerName>Avicenna.AI</manufacturerName>
    <manufacturerSrn>FR-MF-000000324</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039092</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>++B826CINACHEST10VN</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:54:18.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>B826CINAASPECTS140</udiDi>
    <basicUdiDi>B-B826CINAASPECTS140</basicUdiDi>
    <tradeName>CINA-ASPECTS</tradeName>
    <deviceName>CINA-ASPECTS</deviceName>
    <manufacturerName>Avicenna.AI</manufacturerName>
    <manufacturerSrn>FR-MF-000000324</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039092</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>++B826CINAASPECTS14NS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:54:17.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>B826CINA100</udiDi>
    <basicUdiDi>B-B826CINA100</basicUdiDi>
    <tradeName>CINA</tradeName>
    <deviceName>CINA</deviceName>
    <manufacturerName>Avicenna.AI</manufacturerName>
    <manufacturerSrn>FR-MF-000000324</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039092</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>++B826CINA10RR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T20:54:15.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077490412</udiDi>
    <basicUdiDi>B-86989077490412</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Angiographic syringe</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - AS8010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:17:06.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077489904</udiDi>
    <basicUdiDi>B-86989077489904</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Angiographic syringe</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - AS8005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:17:02.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077489836</udiDi>
    <basicUdiDi>B-86989077489836</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Angiographic syringe</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - AS8004</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:17:01.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077489690</udiDi>
    <basicUdiDi>B-86989077489690</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Angiographic syringe</deviceName>
    <manufacturerName>Ares Medikal Sanayi Ticaret Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000029015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039082</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - AS8002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:16:59.814Z</lastUpdated>
  </row>
</eudamedExport>