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<eudamedExport entity="devices">
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    <udiDi>06925816649622</udiDi>
    <basicUdiDi>69449327FF03A0030LL</basicUdiDi>
    <tradeName>Urimed® Vision  Male External Catehter</tradeName>
    <deviceName>Male External 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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2962515A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:12.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816640551</udiDi>
    <basicUdiDi>69449327FA01G03D2</basicUdiDi>
    <tradeName>Welllead Tracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Tracheal Tube with Evacuation Lumen</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>A01G06604F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:10.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816640483</udiDi>
    <basicUdiDi>69449327FA01A13C7</basicUdiDi>
    <tradeName>Welllead Tracheal Tube with Evacuation Lumen</tradeName>
    <deviceName>Tracheal Tube with Evacuation Lumen</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>A01F06601F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:09.537Z</lastUpdated>
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  <row>
    <udiDi>06925816640001</udiDi>
    <basicUdiDi>69449327FF04E04FG</basicUdiDi>
    <tradeName>Wellead Urine Meter Hooks</tradeName>
    <deviceName>Urine Meter Hooks</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F04E010130</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:08.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816639999</udiDi>
    <basicUdiDi>69449327FF04E03FE</basicUdiDi>
    <tradeName>Wellead Urine Meter Hooks</tradeName>
    <deviceName>Urine Meter Hooks</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F04E010120</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:07.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816634772</udiDi>
    <basicUdiDi>69449327FU10A04LE</basicUdiDi>
    <tradeName>Wellead Irrigation Tubing Set</tradeName>
    <deviceName>Irrigation Tubing Set</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>A0380</emdnCode>
    <emdnDescription>TUBULAR DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U10A040370</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:07.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816634758</udiDi>
    <basicUdiDi>69449327FU10A02LA</basicUdiDi>
    <tradeName>Wellead Irrigation Tubing Set</tradeName>
    <deviceName>Irrigation Tubing Set</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>A0380</emdnCode>
    <emdnDescription>TUBULAR DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U10A040170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:06.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816634734</udiDi>
    <basicUdiDi>69449327FU10A03LC</basicUdiDi>
    <tradeName>Wellead Portable Roller Irrigation Pump</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>A03010299</emdnCode>
    <emdnDescription>IRRIGATION CONTROLLERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U10A010410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:05.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816634680</udiDi>
    <basicUdiDi>69449327FU15A01MB</basicUdiDi>
    <tradeName>Wellead Neddle Guide</tradeName>
    <deviceName>Needle Guide</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A018002</emdnCode>
    <emdnDescription>NEEDLE GUIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U15A010110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:04.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816626982</udiDi>
    <basicUdiDi>69449327FF01B00E4</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>AW6112</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:46:00.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816626951</udiDi>
    <basicUdiDi>69449327FF01B01E6</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>AW6106</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:59.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816617027</udiDi>
    <basicUdiDi>69449327FU04B01LW</basicUdiDi>
    <tradeName>Wellead Stone Retrieval Basket</tradeName>
    <deviceName>Stone Retrieval Basket</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>URINARY STONE RETRIEVAL BASKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U04B011710</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:59.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816607585</udiDi>
    <basicUdiDi>69449327FN01D02HS</basicUdiDi>
    <tradeName>Drainage System</tradeName>
    <deviceName>Drainage System</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>SURGICAL DRAINAGE CONNECTION MEDICAL TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N01D020610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:58.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816607462</udiDi>
    <basicUdiDi>69449327FA03A01CE</basicUdiDi>
    <tradeName>Wellead Endobronchial Tube</tradeName>
    <deviceName>Endobronchial 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>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03H01281F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:57.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816607318</udiDi>
    <basicUdiDi>69449327FA01G12D3</basicUdiDi>
    <tradeName>Welllead Reinforced Tracheal Tube</tradeName>
    <deviceName>Reinforced 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, REINFORCED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FA01G12301F</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:56.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816607288</udiDi>
    <basicUdiDi>69449327FA04A02CP</basicUdiDi>
    <tradeName>Wellead Tracheal Tube Introducer</tradeName>
    <deviceName>Tracheal Tube Introducer</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>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A04A020615</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:55.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816607240</udiDi>
    <basicUdiDi>69449327FA04A01CM</basicUdiDi>
    <tradeName>Wellead Tracheal Tube Introducer</tradeName>
    <deviceName>Tracheal Tube Introducer</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>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A04A011013</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:55.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816602306</udiDi>
    <basicUdiDi>69449327FU04D02MA</basicUdiDi>
    <tradeName>Wellead Endoscopic Seal</tradeName>
    <deviceName>Endoscopic Seal</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>SINGLE-USE INSTRUMENTS FOR UROGENITAL ENDOSCOPY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>O05A010310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:45:54.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816677212</udiDi>
    <basicUdiDi>69449327FN01B01HE</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>MDR 2017/745</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24133018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:42:53.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925816677229</udiDi>
    <basicUdiDi>69449327FN01B01HE</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>MDR 2017/745</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24133618</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:42:53.066Z</lastUpdated>
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