<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936841238835</udiDi>
    <basicUdiDi>69368412IS05TV</basicUdiDi>
    <tradeName>PRIMELIFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>051124</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:30.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936841238842</udiDi>
    <basicUdiDi>69368412IS05TV</basicUdiDi>
    <tradeName>PRIMELIFE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>051125</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:30.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976775</udiDi>
    <basicUdiDi>69509009CEIKRW</basicUdiDi>
    <tradeName>06942033976775</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM03B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:02:13.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976768</udiDi>
    <basicUdiDi>69509009CEIKRW</basicUdiDi>
    <tradeName>06942033976768</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM02B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:02:12.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976751</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976751</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:02:10.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976744</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976744</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F70</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:02:09.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976737</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976737</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:02:03.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976720</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976720</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:02:02.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976713</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976713</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:02:01.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976706</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976706</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:59.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976690</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976690</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:53.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976683</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976683</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI5F10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:52.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976676</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976676</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:51.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976669</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976669</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F70</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:50.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976652</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976652</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:44.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976645</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976645</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:43.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976638</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976638</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:41.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976621</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976621</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:40.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976614</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976614</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:35.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942033976607</udiDi>
    <basicUdiDi>69509009MSFB</basicUdiDi>
    <tradeName>06942033976607</tradeName>
    <deviceName>Mini Sheath</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>MDR 2017/745</legislation>
    <emdnCode>C0504</emdnCode>
    <emdnDescription>ARTERIAL INTRODUCTION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI4F10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T01:01:33.473Z</lastUpdated>
  </row>
</eudamedExport>