<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060911403654</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403654</tradeName>
    <deviceName>Sterile Wound Protectors for single use</deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:03.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653341634</udiDi>
    <basicUdiDi>40392390000024462R</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName>Balloon for extraperitoneal distention</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EJ870P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:47:57.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358449</udiDi>
    <basicUdiDi>0850015358449SL</basicUdiDi>
    <tradeName>Rigicon</tradeName>
    <deviceName>Rigicon HL Dilator (Sterile)</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSUD-1012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:12:49.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358425</udiDi>
    <basicUdiDi>0850015358425S6</basicUdiDi>
    <tradeName>Rigicon</tradeName>
    <deviceName>Rigicon HL Dilator (Sterile)</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSUD-1314</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:12:49.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850015358418</udiDi>
    <basicUdiDi>0850015358418S9</basicUdiDi>
    <tradeName>Rigicon</tradeName>
    <deviceName>Rigicon HL Dilator (Sterile)</deviceName>
    <manufacturerName>Rigicon, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027758</manufacturerSrn>
    <authorisedRepresentativeName>Rigicon B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013173</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSUD-1112</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:12:45.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964004689758</udiDi>
    <basicUdiDi>89640046898964004689758SM</basicUdiDi>
    <tradeName>UTERINE PROBE ACCORDING TO SIMS FLEXIBLE CURVED OD 4 MM LENGTH 330 MM</tradeName>
    <deviceName>UTERINE PROBE ACCORDING TO SIMS FLEXIBLE CURVED OD 4 MM LENGTH 330 MM</deviceName>
    <manufacturerName>Ayyat Steel</manufacturerName>
    <manufacturerSrn>PK-MF-000047283</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK AUTHORISED REPRESENTATIVE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000047163</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-1620.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:26:26.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964004689710</udiDi>
    <basicUdiDi>89640046898964004689710RR</basicUdiDi>
    <tradeName>UTERINE DILATOR ACCORDING TO HEGAR D=6.0 MM LENGTH 185 MM</tradeName>
    <deviceName>UTERINE DILATOR ACCORDING TO HEGAR D=6.0 MM LENGTH 185 MM</deviceName>
    <manufacturerName>Ayyat Steel</manufacturerName>
    <manufacturerSrn>PK-MF-000047283</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK AUTHORISED REPRESENTATIVE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000047163</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-1630.13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:26:19.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964004689703</udiDi>
    <basicUdiDi>89640046898964004689703RU</basicUdiDi>
    <tradeName>UTERINE DILATOR ACCORDING TO HEGAR D=5.0MM LENGTH 185 MM</tradeName>
    <deviceName>UTERINE DILATOR ACCORDING TO HEGAR D=5.0 MM LENGTH 185 MM</deviceName>
    <manufacturerName>Ayyat Steel</manufacturerName>
    <manufacturerSrn>PK-MF-000047283</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK AUTHORISED REPRESENTATIVE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000047163</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-1630.12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:26:19.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964004689697</udiDi>
    <basicUdiDi>89640046898964004689697SS</basicUdiDi>
    <tradeName>UTERINE DILATOR ACCOEDING TO HEGAR D=4.0MM LENGTH 185 MM</tradeName>
    <deviceName>UTERINE DILATOR ACCOEDING TO HEGAR D=4.0MM LENGTH 185 MM</deviceName>
    <manufacturerName>Ayyat Steel</manufacturerName>
    <manufacturerSrn>PK-MF-000047283</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK AUTHORISED REPRESENTATIVE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000047163</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-1630.11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:26:18.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964004689680</udiDi>
    <basicUdiDi>89640046898964004689680S9</basicUdiDi>
    <tradeName>UTERINE DILATOR ACCORDING TO HEGAR D=3.0MM LENGTH 185 MM</tradeName>
    <deviceName>UTERINE DILATORE ACCOEDING TO HEGAR D=3.0 MM LENGTH 185 MM</deviceName>
    <manufacturerName>Ayyat Steel</manufacturerName>
    <manufacturerSrn>PK-MF-000047283</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK AUTHORISED REPRESENTATIVE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000047163</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-1630.10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:26:17.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964004689673</udiDi>
    <basicUdiDi>89640046898964004689673SC</basicUdiDi>
    <tradeName>UTERINE DILATOR ACCORDING TO HEGAR D=2.0 MM LENGTH 185 MM</tradeName>
    <deviceName>UTERINE DILATOR ACCORDING TO HEGAR D=2.0 MM LENGTH 185 MM</deviceName>
    <manufacturerName>Ayyat Steel</manufacturerName>
    <manufacturerSrn>PK-MF-000047283</manufacturerSrn>
    <authorisedRepresentativeName>EU-UK AUTHORISED REPRESENTATIVE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000047163</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32-1630.09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:26:13.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403661</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403661</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403678</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403678</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403685</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403685</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403692</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403692</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403708</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403708</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403715</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403715</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403722</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403722</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPF-14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403739</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403739</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPR-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911403746</udiDi>
    <basicUdiDi>506091140SWPG2</basicUdiDi>
    <tradeName>05060911403746</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GENMED ENTERPRISES INTERNATIONAL LTD</manufacturerName>
    <manufacturerSrn>GB-MF-000010687</manufacturerSrn>
    <authorisedRepresentativeName>GENMED ENTERPRISES MEDICAL LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000010419</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K01020117</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY DILATORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-WPR-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-20T09:47:31.373Z</lastUpdated>
  </row>
</eudamedExport>