<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00857042007401</udiDi>
    <basicUdiDi>0857042007ACQMAPCATHNW</basicUdiDi>
    <tradeName>AcQMap 3D Imaging and Mapping Catheter</tradeName>
    <deviceName>AcQMap 3D Imaging and Mapping Catheter</deviceName>
    <manufacturerName>Acutus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019413</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:41:41.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>10846835000665</udiDi>
    <basicUdiDi>08468350a0001EP</basicUdiDi>
    <tradeName>REFSTAR with QWIKPATCH External Reference Patch</tradeName>
    <deviceName>CARTO 3 System/
REFSTAR with QWIKPATCH/
REFSTAR PLUS with QWIKPATCH External Reference Patch</deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>34N01M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:05:47.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000023QG</udiDi>
    <basicUdiDi>B-USMF000014219000023QG</basicUdiDi>
    <tradeName>NOGASTAR CARDIOLOGY CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>120708S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:23.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-USMF000014219000022QE</udiDi>
    <basicUdiDi>B-USMF000014219000022QE</basicUdiDi>
    <tradeName>NOGASTAR CARDIOLOGY CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>120707S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:38:22.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>10846835008821</udiDi>
    <basicUdiDi>08468350a0001EP</basicUdiDi>
    <tradeName>REFSTAR PLUS with QWIKPATCH External Reference Patch</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>XRPP8Y</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:44:13.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>20846835000129</udiDi>
    <basicUdiDi>08468350a0001EP</basicUdiDi>
    <tradeName>CARTO 3 System External Reference Patches</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CREFP6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:15:18.591Z</lastUpdated>
  </row>
</eudamedExport>