<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>05708265015474</udiDi>
    <basicUdiDi>57082651001-1CS40DJ</basicUdiDi>
    <tradeName>LiNA Clear Sight Wipe</tradeName>
    <deviceName>LiNA Clear Sight Wipe</deviceName>
    <manufacturerName>LiNA Medical AG</manufacturerName>
    <manufacturerSrn>CH-MF-000046832</manufacturerSrn>
    <authorisedRepresentativeName>LiNA Medical Polska Sp. z o.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000039364</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K0180</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-40</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:09:56.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630714</udiDi>
    <basicUdiDi>542502563-PPF001-Y4</basicUdiDi>
    <tradeName>05425025630714</tradeName>
    <deviceName>Fistura pack</deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-PR-000000039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06FISPACK6F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:27.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630295</udiDi>
    <basicUdiDi>542502563-PPV001-5P</basicUdiDi>
    <tradeName>CR45i pack</tradeName>
    <deviceName>Veineo Pack</deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-PR-000000039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06CR45IPACK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:26.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630165</udiDi>
    <basicUdiDi>542502563-PPH001-YS</basicUdiDi>
    <tradeName>Rafaelo pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-PR-000000039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06RAFAELOPACK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:25.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051302505</udiDi>
    <basicUdiDi>54200513-TF11-NGW-SU-GT</basicUdiDi>
    <tradeName>Sterile Non-Vascular Guidewires</tradeName>
    <deviceName>Sterile Non-Vascular Guidewires</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020114</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GW01-35450</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:01:48.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>05420051300136</udiDi>
    <basicUdiDi>54200513-TF11-NGW-SU-GT</basicUdiDi>
    <tradeName>Sterile Non-Vascular Guidewires</tradeName>
    <deviceName>Sterile Non-Vascular Guidewires</deviceName>
    <manufacturerName>G-FLEX FLEXIBLE INSTRUMENTS EUROPE</manufacturerName>
    <manufacturerSrn>BE-MF-000000623</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020114</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21435400BS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:55:16.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404030400062</udiDi>
    <basicUdiDi>54040304PPGBGL</basicUdiDi>
    <tradeName>Gastric Bypass Procedure Pack</tradeName>
    <deviceName>Gastric Bypass Procedure Pack</deviceName>
    <manufacturerName>Duo-Med</manufacturerName>
    <manufacturerSrn>BE-PR-000000043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010102</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PP-GB-7/9-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:45:28.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404030400055</udiDi>
    <basicUdiDi>54040304PPSGJ2</basicUdiDi>
    <tradeName>Sleeve Gastrectomy Procedure Pack</tradeName>
    <deviceName>Sleeve Gastrectomy Procedure Pack</deviceName>
    <manufacturerName>Duo-Med</manufacturerName>
    <manufacturerSrn>BE-PR-000000043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010102</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PP-SG-8\10-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:45:27.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404030400024</udiDi>
    <basicUdiDi>54040304PPLCOLONRY</basicUdiDi>
    <tradeName>Hemicolectomy left procedure pack</tradeName>
    <deviceName>Hemicolectomy left procedure pack</deviceName>
    <manufacturerName>Duo-Med</manufacturerName>
    <manufacturerSrn>BE-PR-000000043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010102</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PP-LCOLON-5/7-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T07:45:26.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>05213013380594</udiDi>
    <basicUdiDi>521301338LAP-GYN-SETTU</basicUdiDi>
    <tradeName>LAPSET2</tradeName>
    <deviceName>ΛΑΠΑΡΟΣΚΟΠΙΚΟ ΣΕΤ ΓΥΝΑΙΚΟΛΟΓΙΚΩΝ ΕΠΕΜΒΑΣΕΩΝ</deviceName>
    <manufacturerName>ΜΕΝΤΙΓΟΥΕΙ ΕΙΣΑΓΩΓΗ &amp; ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΩΝ ΝΟΣΟΚΟΜΕΙΟΑΚΩΝ ΜΗΧΑΝΗΜΑΤΩΝ Μ. Ε.Π.Ε.</manufacturerName>
    <manufacturerSrn>GR-PR-000020404</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAPSET2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:46:41.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>05213013380501</udiDi>
    <basicUdiDi>521301338LAP-CHOL-SETEC</basicUdiDi>
    <tradeName>UNISET005</tradeName>
    <deviceName>ΣΕΤ ΛΑΠΑΡΟΣΚΟΠΙΚΗΣ ΧΟΛΟΚΥΣΤΕΚΤΟΜΗΣ</deviceName>
    <manufacturerName>ΜΕΝΤΙΓΟΥΕΙ ΕΙΣΑΓΩΓΗ &amp; ΕΜΠΟΡΙΑ ΙΑΤΡΙΚΩΝ ΝΟΣΟΚΟΜΕΙΟΑΚΩΝ ΜΗΧΑΝΗΜΑΤΩΝ Μ. Ε.Π.Ε.</manufacturerName>
    <manufacturerSrn>GR-PR-000020404</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UNISET005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:46:40.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911401063</udiDi>
    <basicUdiDi>506091140SUCTIONIRRD7</basicUdiDi>
    <tradeName>05060911401063</tradeName>
    <deviceName>Sterile Suction Irrigation 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>K0199</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA-SI0545-SS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:04:56.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911400028</udiDi>
    <basicUdiDi>506091140TROCARA4</basicUdiDi>
    <tradeName>Sterile trocars for single use (Bladeless basic type)</tradeName>
    <deviceName>Sterile Trocars 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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-TW1275</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:04:55.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911401056</udiDi>
    <basicUdiDi>506091140SUCTIONIRRD7</basicUdiDi>
    <tradeName>05060911401056</tradeName>
    <deviceName>Sterile Suction Irrigation 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>K0199</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA-SI1033-SS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:01:08.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911400011</udiDi>
    <basicUdiDi>506091140TROCARA4</basicUdiDi>
    <tradeName>Sterile trocars for single use (Bladeless basic type)</tradeName>
    <deviceName>Sterile Trocars 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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-TW1210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:01:07.208Z</lastUpdated>
  </row>
  <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>05060911401230</udiDi>
    <basicUdiDi>506091140VERESS96</basicUdiDi>
    <tradeName>Sterile Insufflation Needles for Single Use</tradeName>
    <deviceName>Sterile Insufflation Needles 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>K0104</emdnCode>
    <emdnDescription>VERESS NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-VN120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:02.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911401131</udiDi>
    <basicUdiDi>506091140SRBAG6C</basicUdiDi>
    <tradeName>05060911401131</tradeName>
    <deviceName>Sterile Specimen Retrieval Bag 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>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-SRB01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:01.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911401049</udiDi>
    <basicUdiDi>506091140SUCTIONIRRD7</basicUdiDi>
    <tradeName>05060911401049</tradeName>
    <deviceName>Sterile Suction Irrigation 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>K0199</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GA-SI0533-SS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:57:01.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060911400004</udiDi>
    <basicUdiDi>506091140TROCARA4</basicUdiDi>
    <tradeName>Sterile trocars for single use (Bladeless basic type)</tradeName>
    <deviceName>Sterile Trocars 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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GN-TW1510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:56:57.089Z</lastUpdated>
  </row>
</eudamedExport>