<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055896944872</udiDi>
    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SIZE3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:14:22.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055896944902</udiDi>
    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SIZE4</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:14:22.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055896944919</udiDi>
    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SIZE5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:14:22.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055896945442</udiDi>
    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SET</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:14:22.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033638800034</udiDi>
    <basicUdiDi>803363880DLTORD6</basicUdiDi>
    <tradeName>ELLEN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAPI MED S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023733</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A.1005G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:04:05.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>08023279268171</udiDi>
    <basicUdiDi>8023279L0509020200000009F</basicUdiDi>
    <tradeName>SET DILATATORI DI HEGAR - 14 pezzi</tradeName>
    <deviceName>DILATATORI RIUTILIZZABILI</deviceName>
    <manufacturerName>GIMA SPA</manufacturerName>
    <manufacturerSrn>IT-MF-000011004</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020299</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE SPREADERS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>26817</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:33:09.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>07073371092380</udiDi>
    <basicUdiDi>7073371FILE107LK</basicUdiDi>
    <tradeName>Aprikos Medical</tradeName>
    <deviceName>Gyneocological Examination Inst.</deviceName>
    <manufacturerName>Aprikos Medical AS</manufacturerName>
    <manufacturerSrn>NO-MF-000044411</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM18-123-08</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:14:44.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936506301027</udiDi>
    <basicUdiDi>69365063XHSI04WE</basicUdiDi>
    <tradeName>SHINVA</tradeName>
    <deviceName>Reusable Surgical Retractors/Spreaders/hooks</deviceName>
    <manufacturerName>Xinhua Surgical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038108</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011194</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020102</emdnCode>
    <emdnDescription>CERVICAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZG273RB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:08:59.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447124622</udiDi>
    <basicUdiDi>59084472NL117MH</basicUdiDi>
    <tradeName>05908447124622</tradeName>
    <deviceName>Rozwieracz</deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020102</emdnCode>
    <emdnDescription>CERVICAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90.0229.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:35:44.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060228630009</udiDi>
    <basicUdiDi>5060224006ZD</basicUdiDi>
    <tradeName>Femmax</tradeName>
    <deviceName>FEMMAX DILATOR</deviceName>
    <manufacturerName>Medical Devices Technology International Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000006932</manufacturerSrn>
    <authorisedRepresentativeName>MDTi Cyprus Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>CY-AR-000003981</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4006</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:08:39.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250379922458</udiDi>
    <basicUdiDi>4250485300000036ZA</basicUdiDi>
    <tradeName>HEGAR Uterus Dilatator  8,0 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zepf Medical Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005528</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020102</emdnCode>
    <emdnDescription>CERVICAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70-4100-08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T18:39:37.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>14049538079785</udiDi>
    <basicUdiDi>404953800000056BB</basicUdiDi>
    <tradeName>nopa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nopa instruments Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005613</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020103</emdnCode>
    <emdnDescription>TUBES DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KC 750/06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:08:18.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>14049538074698</udiDi>
    <basicUdiDi>404953800000050AX</basicUdiDi>
    <tradeName>nopa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>nopa instruments Medizintechnik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005613</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KB 100/02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T16:08:07.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653153770</udiDi>
    <basicUdiDi>40392390000006602F</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName>Uterus dilator</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM101R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:35:56.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653153787</udiDi>
    <basicUdiDi>40392390000006602F</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM102R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:09:57.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653153794</udiDi>
    <basicUdiDi>40392390000006602F</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM103R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:09:57.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653153800</udiDi>
    <basicUdiDi>40392390000006602F</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM104R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:09:57.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653153817</udiDi>
    <basicUdiDi>40392390000006602F</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM105R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:09:57.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653153824</udiDi>
    <basicUdiDi>40392390000006602F</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM106R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:09:57.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653153831</udiDi>
    <basicUdiDi>40392390000006602F</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0509020199</emdnCode>
    <emdnDescription>GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EM107R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T03:09:57.859Z</lastUpdated>
  </row>
</eudamedExport>