<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05906868954248</udiDi>
    <basicUdiDi>B-05906868954248</basicUdiDi>
    <tradeName>05906868954248</tradeName>
    <deviceName>Torquer</deviceName>
    <manufacturerName>Balton Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000010568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TORQUER</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:28:40.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906868921752</udiDi>
    <basicUdiDi>B-05906868921752</basicUdiDi>
    <tradeName>05906868921752</tradeName>
    <deviceName>Torquer</deviceName>
    <manufacturerName>Balton Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000010568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TORQUER</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:28:38.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901297181463</udiDi>
    <basicUdiDi>B-05901297181463</basicUdiDi>
    <tradeName>05901297181463</tradeName>
    <deviceName>Torquer</deviceName>
    <manufacturerName>Balton Sp. z o.o.</manufacturerName>
    <manufacturerSrn>PL-MF-000010568</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TORQUER</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-29T21:22:38.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994012</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable (ZMAC), GE 7-Pin, Type A</tradeName>
    <deviceName>Zurich Medical Accessory Cable</deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>00512-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:20:15.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729154785</udiDi>
    <basicUdiDi>01915060000000000000476NM</basicUdiDi>
    <tradeName>wireClip™</tradeName>
    <deviceName>wireClip Torquer</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H802221960030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:07.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-855610RS</udiDi>
    <basicUdiDi>B-855610RS</basicUdiDi>
    <tradeName>D-855610RS</tradeName>
    <deviceName>TORQUER PER GUIDA (.010"-.035")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855610</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:29.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-855607S5</udiDi>
    <basicUdiDi>B-855607S5</basicUdiDi>
    <tradeName>D-855607S5</tradeName>
    <deviceName>TORQUER PER GUIDA (.025"- .038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855607</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:28.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-855600RP</udiDi>
    <basicUdiDi>B-855600RP</basicUdiDi>
    <tradeName>D-855600RP</tradeName>
    <deviceName>TORQUER PER GUIDA .010"-.018"</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>855600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:18:27.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>18054953343898</udiDi>
    <basicUdiDi>803300326411000001MR</basicUdiDi>
    <tradeName>18054953343898</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F1703/MGB-1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:06:59.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>18054953343904</udiDi>
    <basicUdiDi>803300326411000001MR</basicUdiDi>
    <tradeName>18054953343904</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F1703/MGB-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-27T05:30:16.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994029</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable (ZMAC), GE 7-Pin, Type C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00512-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994036</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable (ZMAC), GE 7-Pin, Type G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00512-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994043</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable (ZMAC), GE 7-Pin, Type I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>00512-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994050</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable (ZMAC), Philips BNC, Type A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>00512-121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994067</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable (ZMAC), Philips BNC, Type C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00512-122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994074</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable, Philips BNC, Type G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00512-123</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994081</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable, Philips BNC, Type I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>00512-124</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994098</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable, GE 9-Pin, Type A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>00512-021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994104</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable, GE 9-Pin, Type C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00512-022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850022994111</udiDi>
    <basicUdiDi>0850022994005128W</basicUdiDi>
    <tradeName>Zurich Medical Accessory Cable, GE 9-Pin, Type G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zurich Medical</manufacturerName>
    <manufacturerSrn>US-MF-000012091</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0480</emdnCode>
    <emdnDescription>CARDIOVASCULAR GUIDEWIRES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00512-023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:46:10.267Z</lastUpdated>
  </row>
</eudamedExport>