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<eudamedExport entity="devices">
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    <basicUdiDi>B-IntroducersetV4</basicUdiDi>
    <tradeName>Introducer Set</tradeName>
    <deviceName>Introducer Set</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T23:17:15.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803011NR</udiDi>
    <basicUdiDi>B-803011NR</basicUdiDi>
    <tradeName>D-803011NR</tradeName>
    <deviceName>DILATATORE VASCOLARE 13 F 20 cm (.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:24.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803010NP</udiDi>
    <basicUdiDi>B-803010NP</basicUdiDi>
    <tradeName>D-803010NP</tradeName>
    <deviceName>DILATATORE VASCOLARE 16 F 20 cm(.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:20.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803009P6</udiDi>
    <basicUdiDi>B-803009P6</basicUdiDi>
    <tradeName>D-803009P6</tradeName>
    <deviceName>DILATATORE VASCOLARE 14 F 20 cm (.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803009</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:19.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803008P4</udiDi>
    <basicUdiDi>B-803008P4</basicUdiDi>
    <tradeName>D-803008P4</tradeName>
    <deviceName>DILATATORE VASCOLARE 12 F 20 cm (.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:19.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803007P2</udiDi>
    <basicUdiDi>B-803007P2</basicUdiDi>
    <tradeName>D-803007P2</tradeName>
    <deviceName>DILATATORE VASCOLARE 11 F 20 cm (.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:18.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803006NY</udiDi>
    <basicUdiDi>B-803006NY</basicUdiDi>
    <tradeName>D-803006NY</tradeName>
    <deviceName>DILATATORE VASCOLARE 10F 20cm(.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:14.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803005NW</udiDi>
    <basicUdiDi>B-803005NW</basicUdiDi>
    <tradeName>D-803005NW</tradeName>
    <deviceName>DILATATORE VASCOLARE 9F 20cm(.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:13.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803004NU</udiDi>
    <basicUdiDi>B-803004NU</basicUdiDi>
    <tradeName>D-803004NU</tradeName>
    <deviceName>DILATATORE VASCOLARE 8F 20cm(.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:12.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803003NS</udiDi>
    <basicUdiDi>B-803003NS</basicUdiDi>
    <tradeName>D-803003NS</tradeName>
    <deviceName>DILATATORE VASCOLARE 7F 20cm(.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:11.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803002NQ</udiDi>
    <basicUdiDi>B-803002NQ</basicUdiDi>
    <tradeName>D-803002NQ</tradeName>
    <deviceName>DILATATORE VASCOLARE 6F 20cm(.038")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:07.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-803001NN</udiDi>
    <basicUdiDi>B-803001NN</basicUdiDi>
    <tradeName>D-803001NN</tradeName>
    <deviceName>DILATATORE VASCOLARE 5F 20cm(.035")</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:07.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985352082</udiDi>
    <basicUdiDi>B-06972985352082</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS12-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:23:08.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985352075</udiDi>
    <basicUdiDi>B-06972985352075</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS12-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:23:06.983Z</lastUpdated>
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    <udiDi>06972985352068</udiDi>
    <basicUdiDi>B-06972985352068</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS11-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:23:06.190Z</lastUpdated>
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    <udiDi>06972985352051</udiDi>
    <basicUdiDi>B-06972985352051</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS11-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:23:04.695Z</lastUpdated>
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    <udiDi>06972985352044</udiDi>
    <basicUdiDi>B-06972985352044</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS10-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:23:02.179Z</lastUpdated>
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    <udiDi>06972985352037</udiDi>
    <basicUdiDi>B-06972985352037</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS10-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:23:00.583Z</lastUpdated>
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    <udiDi>06972985352020</udiDi>
    <basicUdiDi>B-06972985352020</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS09-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:22:59.904Z</lastUpdated>
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    <udiDi>06972985352013</udiDi>
    <basicUdiDi>B-06972985352013</basicUdiDi>
    <tradeName>Disposable Introducer Set</tradeName>
    <deviceName>Disposable Introducer Set</deviceName>
    <manufacturerName>Ortus Medi-Tech Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000031033</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-IS09-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:22:58.171Z</lastUpdated>
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