<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>04046963909338</udiDi>
    <basicUdiDi>40392390000026202H</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName>Internal Organ Retractor</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PL595SU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:51:31.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333233076</udiDi>
    <basicUdiDi>B-04961333233076</basicUdiDi>
    <tradeName>PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series</tradeName>
    <deviceName>PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series HS-D2622</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333233076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:21.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333225538</udiDi>
    <basicUdiDi>B-04961333225538</basicUdiDi>
    <tradeName>PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series</tradeName>
    <deviceName>PENTAX Medical Bipolar Hot Hemostasis Forceps HS-D Series HS-D2618</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333225538</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:19.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002144408</udiDi>
    <basicUdiDi>0827002CINC050-033_B-1JQ</basicUdiDi>
    <tradeName>Peel-Away®</tradeName>
    <deviceName>Introducer/Access Devices, Peel-Away® Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>073909</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:12.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002143067</udiDi>
    <basicUdiDi>0827002CINC050-033_B-3JU</basicUdiDi>
    <tradeName>00827002143067</tradeName>
    <deviceName>Introducer/Access Devices, Safety Wire Guide Introducer</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>074112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:44:11.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>20884521066561</udiDi>
    <basicUdiDi>0763000B00005627V</basicUdiDi>
    <tradeName>Endo-Lube™ Auto Suture™</tradeName>
    <deviceName>Endo-Lube™ Auto Suture™ Seal</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000028763</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:13:21.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290017376097</udiDi>
    <basicUdiDi>07290017376HXP004WN</basicUdiDi>
    <tradeName>HandX Monopolar Hook</tradeName>
    <deviceName>HandX™ Monopolar Instruments</deviceName>
    <manufacturerName>HumanTouch Surgical LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000009116</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-30-044-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:01:04.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>E296DPHKC0533G0</udiDi>
    <basicUdiDi>++E296DOLPHIN48</basicUdiDi>
    <tradeName>DOLPHIN</tradeName>
    <deviceName>DOLPHIN</deviceName>
    <manufacturerName>ab medica spa</manufacturerName>
    <manufacturerSrn>IT-MF-000029717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPH-KC0533G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T15:44:23.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290017376202</udiDi>
    <basicUdiDi>07290017376HXP004WN</basicUdiDi>
    <tradeName>HandX Monopolar Spatula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanTouch Surgical LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000009116</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-30-075-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:36:38.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290017376219</udiDi>
    <basicUdiDi>07290017376HXP004WN</basicUdiDi>
    <tradeName>HandX Monopolar Scissors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HumanTouch Surgical LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000009116</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP IIb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011192</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20-30-048-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T19:36:38.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977770461079</udiDi>
    <basicUdiDi>B-06977770461079</basicUdiDi>
    <tradeName>06977770461079</tradeName>
    <deviceName>Disposable Suction and lrrigation Sets</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDSIS-A-10N</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:29:56.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975238202837</udiDi>
    <basicUdiDi>B-06975238202837</basicUdiDi>
    <tradeName>Sterile Suction &amp; Irrigation Tube for Single Use</tradeName>
    <deviceName>Sterile Suction &amp; Irrigation Tube for Single Use</deviceName>
    <manufacturerName>Changzhou Intl. Trade &amp; Enterprises Cooperative Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010512</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CX4502-5</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:53.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118373615</udiDi>
    <basicUdiDi>B-06973118373615</basicUdiDi>
    <tradeName>06973118373615</tradeName>
    <deviceName>Disposable Suction and lrrigation Sets</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDSIS-B-10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:42:31.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118373608</udiDi>
    <basicUdiDi>B-06973118373608</basicUdiDi>
    <tradeName>06973118373608</tradeName>
    <deviceName>Disposable Suction and lrrigation Sets</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDSIS-B-5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:42:30.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118373592</udiDi>
    <basicUdiDi>B-06973118373592</basicUdiDi>
    <tradeName>06973118373592</tradeName>
    <deviceName>Disposable Suction and lrrigation Sets</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDSIS-B-3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:42:29.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118373585</udiDi>
    <basicUdiDi>B-06973118373585</basicUdiDi>
    <tradeName>06973118373585</tradeName>
    <deviceName>Disposable Suction and lrrigation Sets</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDSIS-A-10</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:42:28.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973118373578</udiDi>
    <basicUdiDi>B-06973118373578</basicUdiDi>
    <tradeName>06973118373578</tradeName>
    <deviceName>Disposable Suction and lrrigation Sets</deviceName>
    <manufacturerName>ChangZhou 3R Medical Device Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001123</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020199</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRDSIS-A-5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:42:24.771Z</lastUpdated>
  </row>
</eudamedExport>