<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06972985351153</udiDi>
    <basicUdiDi>B-06972985351153</basicUdiDi>
    <tradeName>Disposable Guide Wire</tradeName>
    <deviceName>Disposable Guide Wire</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>C04030102</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GW-P32150J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:15.388Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985351146</udiDi>
    <basicUdiDi>B-06972985351146</basicUdiDi>
    <tradeName>Disposable Guide Wire</tradeName>
    <deviceName>Disposable Guide Wire</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>C04030102</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GW-P28150J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:14.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985351139</udiDi>
    <basicUdiDi>B-06972985351139</basicUdiDi>
    <tradeName>Disposable Guide Wire</tradeName>
    <deviceName>Disposable Guide Wire</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>C04030102</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GW-P25150J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:09.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985351122</udiDi>
    <basicUdiDi>B-06972985351122</basicUdiDi>
    <tradeName>Disposable Guide Wire</tradeName>
    <deviceName>Disposable Guide Wire</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>C04030102</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GW-P21150J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:08.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985351115</udiDi>
    <basicUdiDi>B-06972985351115</basicUdiDi>
    <tradeName>Disposable Guide Wire</tradeName>
    <deviceName>Disposable Guide Wire</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>C04030102</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GW-P18150J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:08.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985351108</udiDi>
    <basicUdiDi>B-06972985351108</basicUdiDi>
    <tradeName>Disposable Guide Wire</tradeName>
    <deviceName>Disposable Guide Wire</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>C04030102</emdnCode>
    <emdnDescription>DIAGNOSTIC CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, NON-HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-GW-P14150J</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:07.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985351016</udiDi>
    <basicUdiDi>B-06972985351016</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-IS12-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:02.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985351009</udiDi>
    <basicUdiDi>B-06972985351009</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-IS11-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:01.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350996</udiDi>
    <basicUdiDi>B-06972985350996</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-IS10-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:21:01.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350989</udiDi>
    <basicUdiDi>B-06972985350989</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-IS09-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:59.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350934</udiDi>
    <basicUdiDi>B-06972985350934</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-IS06-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:55.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350927</udiDi>
    <basicUdiDi>B-06972985350927</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-IS06-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:54.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350972</udiDi>
    <basicUdiDi>B-06972985350972</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-IS08-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:52.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350958</udiDi>
    <basicUdiDi>B-06972985350958</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-IS07-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:52.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350910</udiDi>
    <basicUdiDi>B-06972985350910</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-IS06-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:34.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350897</udiDi>
    <basicUdiDi>B-06972985350897</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-IS05-03</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:33.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350880</udiDi>
    <basicUdiDi>B-06972985350880</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-IS05-02</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:32.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350873</udiDi>
    <basicUdiDi>B-06972985350873</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-IS05-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:32.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350859</udiDi>
    <basicUdiDi>B-06972985350859</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-IS04-01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:27.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972985350828</udiDi>
    <basicUdiDi>B-06972985350828</basicUdiDi>
    <tradeName>Disposable Pressure Line</tradeName>
    <deviceName>Disposable Pressure Line</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020102</emdnCode>
    <emdnDescription>HIGH PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OM-PL-1221</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T13:20:26.507Z</lastUpdated>
  </row>
</eudamedExport>