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    <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>
  </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>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>
  </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>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>
  </row>
  <row>
    <udiDi>08033772320580</udiDi>
    <basicUdiDi>803377232CAT-U0503ML</basicUdiDi>
    <tradeName>Catetere 2PP-9L / 2PP-9L Catheter</tradeName>
    <deviceName>CATHETERS FOR URETHRAL PRESSOR WITHOUT BALLOON</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U05030101</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 1-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2PP-9L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:39:32.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772320801</udiDi>
    <basicUdiDi>803377232CAT-U0503ML</basicUdiDi>
    <tradeName>5PPV-9 Catheter</tradeName>
    <deviceName>CATHETERS FOR URETHRAL PRESSOR WITHOUT BALLOON</deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U05030101</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 1-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5PPV-9</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:47:18.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033772320887</udiDi>
    <basicUdiDi>803377232CAT-U0503ML</basicUdiDi>
    <tradeName>2omni-6N Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000025691</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U05030101</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 1-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2omni-6N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:43.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133466</udiDi>
    <basicUdiDi>69449327FU08A01MM</basicUdiDi>
    <tradeName>Wellead Urodynamic 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>UNKNOWN</legislation>
    <emdnCode>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A010710</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881133473</udiDi>
    <basicUdiDi>69449327FU08A01MM</basicUdiDi>
    <tradeName>Wellead Urodynamic 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>UNKNOWN</legislation>
    <emdnCode>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A010810</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:29.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936881165160</udiDi>
    <basicUdiDi>69449327FU08A02MP</basicUdiDi>
    <tradeName>Wellead Urodynamic 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>UNKNOWN</legislation>
    <emdnCode>U05030102</emdnCode>
    <emdnDescription>URETHRAL PRESSURE PROFILE CATHETERS WITHOUT BALLOON, 2-WAY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U08A020610</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:09.783Z</lastUpdated>
  </row>
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