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<eudamedExport entity="devices">
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    <basicUdiDi>69449327FN01D05HY</basicUdiDi>
    <tradeName>Wellead Bile-T Tube</tradeName>
    <deviceName>Bile T-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>U040203</emdnCode>
    <emdnDescription>NEPHROSTOMY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N01D051220</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:59.160Z</lastUpdated>
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    <udiDi>06944932785137</udiDi>
    <basicUdiDi>69449327FU04C01M3</basicUdiDi>
    <tradeName>Wellead Specimen Collection Bottle</tradeName>
    <deviceName>Specimen Collection Bottle</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>U090199</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>79880200</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:58.363Z</lastUpdated>
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    <udiDi>06944932785113</udiDi>
    <basicUdiDi>69449327FU04D01M8</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090399</emdnCode>
    <emdnDescription>SINGLE-USE INSTRUMENTS FOR UROGENITAL ENDOSCOPY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U04D010110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:57.564Z</lastUpdated>
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  <row>
    <udiDi>06944932759411</udiDi>
    <basicUdiDi>69449327FA03A02CG</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A03A02281F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:14.556Z</lastUpdated>
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  <row>
    <udiDi>06944932738331</udiDi>
    <basicUdiDi>69449327FA04A03CR</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A04A031012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:00:59.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932738270</udiDi>
    <basicUdiDi>69449327FA04A04CT</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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A04A040520</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:00:58.315Z</lastUpdated>
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  <row>
    <udiDi>06944932738287</udiDi>
    <basicUdiDi>69449327FA04A05CV</basicUdiDi>
    <tradeName>Wellead Tracheal Tube Introducer</tradeName>
    <deviceName>Wellead 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>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A04A051020</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:00:54.323Z</lastUpdated>
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  <row>
    <udiDi>06936881164743</udiDi>
    <basicUdiDi>69449327FF01C01EB</basicUdiDi>
    <tradeName>All Silicone Foley Catheter with Temperature Sensor</tradeName>
    <deviceName>All Silicone Foley Catheter with Temperature Sensor</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>U0103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01C011208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:58.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881161056</udiDi>
    <basicUdiDi>69449327FU06A04MD</basicUdiDi>
    <tradeName>Ureteral Catheter</tradeName>
    <deviceName>Ureteral 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>U020101</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH CYLINDRICAL TIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U06A040612</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:57.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881158339</udiDi>
    <basicUdiDi>69449327FU06A06MH</basicUdiDi>
    <tradeName>Ureteral Catheter</tradeName>
    <deviceName>Ureteral 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>U020101</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH CYLINDRICAL TIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U06A060412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:49.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881158285</udiDi>
    <basicUdiDi>69449327FU06A07MK</basicUdiDi>
    <tradeName>Ureteral Catheter</tradeName>
    <deviceName>Ureteral 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>U020101</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH CYLINDRICAL TIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U06A070412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:46.571Z</lastUpdated>
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  <row>
    <udiDi>06936881158247</udiDi>
    <basicUdiDi>69449327FU06A05MF</basicUdiDi>
    <tradeName>Ureteral Catheter</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>U020101</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH CYLINDRICAL TIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U06A050412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:45.850Z</lastUpdated>
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  <row>
    <udiDi>06936881157585</udiDi>
    <basicUdiDi>69449327FU08A03MR</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>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A030710</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:44.170Z</lastUpdated>
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  <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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A101607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:42.572Z</lastUpdated>
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  <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>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A020810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:37.781Z</lastUpdated>
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    <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>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01D02061F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:20.118Z</lastUpdated>
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    <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>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U03B011013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:17.701Z</lastUpdated>
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    <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>U050402</emdnCode>
    <emdnDescription>INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08B011010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:15.316Z</lastUpdated>
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    <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>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A010610</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:12.084Z</lastUpdated>
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    <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>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AWB618</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:10.141Z</lastUpdated>
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