<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08680081330665</udiDi>
    <basicUdiDi>B-08680081330665</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE MINI SLING S</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTMS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:16.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330658</udiDi>
    <basicUdiDi>B-08680081330658</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE MINI SLING M</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTM</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:15.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330610</udiDi>
    <basicUdiDi>B-08680081330610</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE HELICAL SET</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTHS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:13.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330603</udiDi>
    <basicUdiDi>B-08680081330603</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE TOT SET</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTTS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:11.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330597</udiDi>
    <basicUdiDi>B-08680081330597</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE SUPRAPUBIC SET</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTPS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:09.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330559</udiDi>
    <basicUdiDi>B-08680081330559</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE RECTOCELE SET</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTRS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:08.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330542</udiDi>
    <basicUdiDi>B-08680081330542</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE CYSTOCELE SET</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTCS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:07.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330535</udiDi>
    <basicUdiDi>B-08680081330535</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE MINI SLING L</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVTML</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:04.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330528</udiDi>
    <basicUdiDi>B-08680081330528</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE 10X600MM</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVT10600</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:03.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680081330511</udiDi>
    <basicUdiDi>B-08680081330511</basicUdiDi>
    <tradeName>DÜZEY SVT</tradeName>
    <deviceName>DUZEY SVT VAGINAL TAPE</deviceName>
    <manufacturerName>DÜZEY MEDİKAL CİHAZLAR SANAYİ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000016259</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U070101</emdnCode>
    <emdnDescription>SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVT10450</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T00:08:02.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905159000104</udiDi>
    <basicUdiDi>8905159UDRLBG</basicUdiDi>
    <tradeName>NULIFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRK HEALTHCARE PVT. LTD.</manufacturerName>
    <manufacturerSrn>IN-MF-000019843</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDRLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:35.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905159000111</udiDi>
    <basicUdiDi>8905159UDRLBG</basicUdiDi>
    <tradeName>NULIFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRK HEALTHCARE PVT. LTD.</manufacturerName>
    <manufacturerSrn>IN-MF-000019843</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDRLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:35.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905159000128</udiDi>
    <basicUdiDi>8905159UDRLBG</basicUdiDi>
    <tradeName>NULIFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRK HEALTHCARE PVT. LTD.</manufacturerName>
    <manufacturerSrn>IN-MF-000019843</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDRLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:35.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905159000135</udiDi>
    <basicUdiDi>8905159UDRLBG</basicUdiDi>
    <tradeName>NULIFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRK HEALTHCARE PVT. LTD.</manufacturerName>
    <manufacturerSrn>IN-MF-000019843</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDRLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:35.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905159002962</udiDi>
    <basicUdiDi>8905159UDRLBG</basicUdiDi>
    <tradeName>GALENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRK HEALTHCARE PVT. LTD.</manufacturerName>
    <manufacturerSrn>IN-MF-000019843</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDRLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:34.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905159002979</udiDi>
    <basicUdiDi>8905159UDRLBG</basicUdiDi>
    <tradeName>GALENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRK HEALTHCARE PVT. LTD.</manufacturerName>
    <manufacturerSrn>IN-MF-000019843</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDRLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:34.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08905159002986</udiDi>
    <basicUdiDi>8905159UDRLBG</basicUdiDi>
    <tradeName>GALENA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MRK HEALTHCARE PVT. LTD.</manufacturerName>
    <manufacturerSrn>IN-MF-000019843</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UDRLE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:46:34.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716820130310</udiDi>
    <basicUdiDi>471682013693410HW</basicUdiDi>
    <tradeName>Supersot</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dileh Medical supplies co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000016927</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30020</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:10.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716820130358</udiDi>
    <basicUdiDi>471682013693410HW</basicUdiDi>
    <tradeName>Supersoft</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dileh Medical supplies co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000016927</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30037</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:10.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>04716820130402</udiDi>
    <basicUdiDi>471682013693410HW</basicUdiDi>
    <tradeName>Supersoft</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dileh Medical supplies co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000016927</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30044</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:10.044Z</lastUpdated>
  </row>
</eudamedExport>