<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08905080072935</udiDi>
    <basicUdiDi>8905080BPGWHZ8</basicUdiDi>
    <tradeName>Prime Wire® Straight Tip (Both Side Floppy)</tradeName>
    <deviceName>Guidewires</deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPTN035150HB</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:12.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976055233950</udiDi>
    <basicUdiDi>697605523CA0018R</basicUdiDi>
    <tradeName>06976055233950</tradeName>
    <deviceName>Angiographic Guidewire</deviceName>
    <manufacturerName>SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000037066</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SF.CA11.B89</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-28T11:01:21.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729762553</udiDi>
    <basicUdiDi>01915060000000000000282N6</basicUdiDi>
    <tradeName>FATHOM™</tradeName>
    <deviceName>Fathom Steerable Guidewire</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M001509100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:57:59.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077499668</udiDi>
    <basicUdiDi>B-86989077499668</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Guide Wire</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>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - GW2108</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:18:31.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>86989077452106</udiDi>
    <basicUdiDi>B-86989077452106</basicUdiDi>
    <tradeName>ARES</tradeName>
    <deviceName>Guide wire</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>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARES - GW2107-Guide wire</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T15:05:20.120Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498159676HA</udiDi>
    <basicUdiDi>B-8683498159676HA</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, 038",  Hyrophilic, Distal Thinning, 290  cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0094</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:57:15.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498159669HD</udiDi>
    <basicUdiDi>B-8683498159669HD</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, 035", Hyrophilic, Distal Thinning, 290  cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0093</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:57:15.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498159638H2</udiDi>
    <basicUdiDi>B-8683498159638H2</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, 035",  Hyrophilic, Distal Thinning, 260  cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0090</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:57:09.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498159652GU</udiDi>
    <basicUdiDi>B-8683498159652GU</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, 032", Hyrophilic, Distal Thinning, 290  cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0092</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:57:08.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498159645GX</udiDi>
    <basicUdiDi>B-8683498159645GX</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, 038",  Hyrophilic, Distal Thinning, 260  cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0091</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:57:08.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8683498159621GH</udiDi>
    <basicUdiDi>B-8683498159621GH</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire, 032", Hyrophilic, Distal Thinning, 260  cm</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0089</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T13:57:06.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-86814100611513D</udiDi>
    <basicUdiDi>B-86814100611513D</basicUdiDi>
    <tradeName>Inwire</tradeName>
    <deviceName>Inwire Guidewire / 0,035" / Super Strong</deviceName>
    <manufacturerName>İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000019963</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA0115</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T12:27:03.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400640</udiDi>
    <basicUdiDi>B-18904314400640</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-035-STGES</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:34.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400633</udiDi>
    <basicUdiDi>B-18904314400633</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-035-AGES</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:30.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400626</udiDi>
    <basicUdiDi>B-18904314400626</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-038-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:29.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400619</udiDi>
    <basicUdiDi>B-18904314400619</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-038-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:28.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400602</udiDi>
    <basicUdiDi>B-18904314400602</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-038-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:27.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400589</udiDi>
    <basicUdiDi>B-18904314400589</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-035-STG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:23.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400596</udiDi>
    <basicUdiDi>B-18904314400596</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW150-038-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:22.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314400572</udiDi>
    <basicUdiDi>B-18904314400572</basicUdiDi>
    <tradeName>Guidewire</tradeName>
    <deviceName>HYDROWIRE Guidewire</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C04020101</emdnCode>
    <emdnDescription>PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HW260-035-AG</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:32:22.031Z</lastUpdated>
  </row>
</eudamedExport>