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<eudamedExport entity="devices">
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    <udiDi>06950203334157</udiDi>
    <basicUdiDi>69502033UGTZE</basicUdiDi>
    <tradeName>06950203334157</tradeName>
    <deviceName>Urological Guidewires</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0602</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3215TSO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:50.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203334119</udiDi>
    <basicUdiDi>69502033UGBYA</basicUdiDi>
    <tradeName>06950203334119</tradeName>
    <deviceName>Urological Guidewires</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UG-3215BSO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:47.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203328132</udiDi>
    <basicUdiDi>69502033UBMYRM</basicUdiDi>
    <tradeName>06950203328132</tradeName>
    <deviceName>Ureteral Dilation Balloon Catheters</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UB-MY04040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:46.301Z</lastUpdated>
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  <row>
    <udiDi>06950203329399</udiDi>
    <basicUdiDi>69502033UBUYSD</basicUdiDi>
    <tradeName>06950203329399</tradeName>
    <deviceName>Ureteral Dilation Balloon Catheters</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U030202</emdnCode>
    <emdnDescription>URETERAL DILATORS, WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UB-UY07060</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:45.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203301074</udiDi>
    <basicUdiDi>69502033SCBR</basicUdiDi>
    <tradeName>06950203301074</tradeName>
    <deviceName>Ureteral Occlusion Devices</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020199</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITHOUT BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-SC07</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:43.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950203305188</udiDi>
    <basicUdiDi>69502033UABT</basicUdiDi>
    <tradeName>06950203305188</tradeName>
    <deviceName>Ureteral Access Sheaths</deviceName>
    <manufacturerName>Innovex Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000015981</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020199</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITHOUT BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVX-UA-1035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:41.596Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949717003123</udiDi>
    <basicUdiDi>69497170DVD1023R9</basicUdiDi>
    <tradeName>Disposable Vaginal Speculum</tradeName>
    <deviceName>Disposable Vaginal Speculum</deviceName>
    <manufacturerName>Ningbo HLS Medical Products Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026849</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0502-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:15.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949717002980</udiDi>
    <basicUdiDi>69497170DESC1024XH</basicUdiDi>
    <tradeName>Disposable Endometrial Suction Cannula</tradeName>
    <deviceName>Disposable Endometrial Suction Cannula</deviceName>
    <manufacturerName>Ningbo HLS Medical Products Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026849</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U080199</emdnCode>
    <emdnDescription>GYNAECOLOGICAL CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:13.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949717002652</udiDi>
    <basicUdiDi>69497170DCB1021GQ</basicUdiDi>
    <tradeName>Disposable Cervical Brush</tradeName>
    <deviceName>Disposable Cervical Brush</deviceName>
    <manufacturerName>Ningbo HLS Medical Products Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026849</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:18:11.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949402860017</udiDi>
    <basicUdiDi>694940280001J4</basicUdiDi>
    <tradeName>06949402860017</tradeName>
    <deviceName>Natural Latex Rubber Condoms</deviceName>
    <manufacturerName>Shandong Ming Yuan Latex Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045347</manufacturerSrn>
    <authorisedRepresentativeName>BioDomi GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016611</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Width:49±2mm(Classic )</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:14:01.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>06946680198429</udiDi>
    <basicUdiDi>69466801GR-NT-GN3L</basicUdiDi>
    <tradeName>Male External Catheter</tradeName>
    <deviceName>Male External Catheter</deviceName>
    <manufacturerName>Ningbo Greatcare Medical Instruments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013677</manufacturerSrn>
    <authorisedRepresentativeName>Greatcare Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005587</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UZ6311</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:12:12.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945144719019</udiDi>
    <basicUdiDi>69451447005QYQ7F</basicUdiDi>
    <tradeName>Cervical Samplers</tradeName>
    <deviceName>Cervical Samplers</deviceName>
    <manufacturerName>CHANGZHOU SHUANGMA MEDICAL DEVICES CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000009732</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089002</emdnCode>
    <emdnDescription>DEVICES FOR GYNAECOLOGICAL CYTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:55.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945144701519</udiDi>
    <basicUdiDi>69451447006KZQ6T</basicUdiDi>
    <tradeName>Nextech Vaginal speculum</tradeName>
    <deviceName>Vaginal Speculums for Single Use</deviceName>
    <manufacturerName>CHANGZHOU SHUANGMA MEDICAL DEVICES CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000009732</manufacturerSrn>
    <authorisedRepresentativeName>Llins Service &amp; Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009077</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U089006</emdnCode>
    <emdnDescription>VAGINAL SPECULUM, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N-6010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:08:46.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932785984</udiDi>
    <basicUdiDi>69449327FF01C02ED</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>F01C021607</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:02:03.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944932785649</udiDi>
    <basicUdiDi>69449327FF01C00E9</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>F01C010802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:01:59.961Z</lastUpdated>
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  <row>
    <udiDi>06944932785298</udiDi>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <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>
</eudamedExport>