<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+B220AORTACT0</udiDi>
    <basicUdiDi>++B220AORTACTQP</basicUdiDi>
    <tradeName>TeraRecon Aorta.CT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:20:57.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220CARDIACCHAMBERSMR10</udiDi>
    <basicUdiDi>++B220CHAMBERSMRZS</basicUdiDi>
    <tradeName>TeraRecon Cardiac.Chambers.MR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:20:57.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220CARDIOVASCCALCT10</udiDi>
    <basicUdiDi>++B220CALCIFICATIONCTLV</basicUdiDi>
    <tradeName>TeraRecon Cardiovascular.Calcification.CT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:20:57.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220INTUITION040</udiDi>
    <basicUdiDi>++B220INTUITIONFV</basicUdiDi>
    <tradeName>Intuition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:20:57.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B220NEURO020</udiDi>
    <basicUdiDi>++B220NeuroFP</basicUdiDi>
    <tradeName>TeraRecon Neuro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:20:57.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>INTUITION04</udiDi>
    <basicUdiDi>B-INTUITION04</basicUdiDi>
    <tradeName>Intuition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Intuition</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:37:06.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>NEURO02</udiDi>
    <basicUdiDi>B-NEURO02</basicUdiDi>
    <tradeName>TeraRecon Neuro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TeraRecon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008772</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Neuro</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T21:24:45.352Z</lastUpdated>
  </row>
</eudamedExport>