<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936881149429</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName>Latex Foley Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A101607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:04.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881135668</udiDi>
    <basicUdiDi>69449327FU08A02MP</basicUdiDi>
    <tradeName>Wellead Urodynamic Catheter</tradeName>
    <deviceName>Urodynamic Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A020810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:04.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881135071</udiDi>
    <basicUdiDi>69449327FA01A02C2</basicUdiDi>
    <tradeName>Tracheal Tube</tradeName>
    <deviceName>Tracheal Tube</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFLESS, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01A02973F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:03.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881135040</udiDi>
    <basicUdiDi>69449327FA01A00BW</basicUdiDi>
    <tradeName>Tracheal Tube</tradeName>
    <deviceName>Tracheal Tube</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01A01971F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:02.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134852</udiDi>
    <basicUdiDi>69449327FA01G09DE</basicUdiDi>
    <tradeName>Tracheal Tube</tradeName>
    <deviceName>Tracheal Tube</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A01G15304F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:01.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134418</udiDi>
    <basicUdiDi>69449327FF01D00EE</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName>Nelaton Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01D02061F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:00.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133510</udiDi>
    <basicUdiDi>69449327FU08C01MX</basicUdiDi>
    <tradeName>Tube Accessories for Urodynamic Catheter</tradeName>
    <deviceName>Tube Accessories for Urodynamic Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FU08C010410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:47:00.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881134234</udiDi>
    <basicUdiDi>69449327FU03B01LP</basicUdiDi>
    <tradeName>Wellead Ureteral Access Sheath</tradeName>
    <deviceName>Ureteral Access Sheath</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U03B011013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:59.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133763</udiDi>
    <basicUdiDi>69449327FO02A02HX</basicUdiDi>
    <tradeName>Wellead Extraction Bag</tradeName>
    <deviceName>Extraction Bag</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O02A020510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:58.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133725</udiDi>
    <basicUdiDi>69449327FO02A01HV</basicUdiDi>
    <tradeName>Wellead Extraction Bag</tradeName>
    <deviceName>Extraction Bag</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O02A010210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:57.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133497</udiDi>
    <basicUdiDi>69449327FU08B01MS</basicUdiDi>
    <tradeName>Welllead Rectal Pressure Catheter</tradeName>
    <deviceName>Rectal Pressure Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08B011010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:56.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133442</udiDi>
    <basicUdiDi>69449327FU08A01MM</basicUdiDi>
    <tradeName>Welllead Urodynamic Catheter</tradeName>
    <deviceName>Urodynamic Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A010610</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:55.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816677205</udiDi>
    <basicUdiDi>69449327FN01B01HE</basicUdiDi>
    <tradeName>Connecting Tube with or without Yankauer Handle</tradeName>
    <deviceName>Connecting Tube with or without Yankauer Handle</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24131818</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:22.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816677199</udiDi>
    <basicUdiDi>69449327FN01A01H9</basicUdiDi>
    <tradeName>Connecting Tube with or without Yankauer Handle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23130018</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:21.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816671944</udiDi>
    <basicUdiDi>69449327FU10A01L8</basicUdiDi>
    <tradeName>Wellead Portable Roller Irrigation Pump</tradeName>
    <deviceName>Portable Roller Irrigation Pump</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010299</emdnCode>
    <emdnDescription>IRRIGATION CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U10A010420</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:19.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816676338</udiDi>
    <basicUdiDi>69449327FA03D01CV</basicUdiDi>
    <tradeName>Endobronchial Blocker Tube</tradeName>
    <deviceName>Endobronchial blocker Tube</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65110518</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:17.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816660443</udiDi>
    <basicUdiDi>69449327FR01A04K3</basicUdiDi>
    <tradeName>Welllead Non-Rebreath Mask</tradeName>
    <deviceName>Non-Rebreath Mask</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>AIR/OXYGEN MASKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01A04013F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:15.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816646331</udiDi>
    <basicUdiDi>69449327FR01E04KP</basicUdiDi>
    <tradeName>Welllead Mesh Nebulizer Kit</tradeName>
    <deviceName>Mesh Nebulizer Kit</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01L021010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:15.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816646157</udiDi>
    <basicUdiDi>69449327FR01E00KF</basicUdiDi>
    <tradeName>Welllead Mesh Nebulizer Kit</tradeName>
    <deviceName>Mesh Nebulizer Kit</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03010304</emdnCode>
    <emdnDescription>AEROSOL THERAPY KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R01L011010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:14.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816652530</udiDi>
    <basicUdiDi>69449327FF01B09EN</basicUdiDi>
    <tradeName>All Silicone Foley Catheter</tradeName>
    <deviceName>All Silicone Foley Catheter</deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AWB618</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:13.540Z</lastUpdated>
  </row>
</eudamedExport>