<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942127845659</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1140A2S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127845673</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1340A2S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127845697</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1540A2S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127845789</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1050A2S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127845796</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1150A2S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127845819</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1350A2S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127845833</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1550A2S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846069</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1040A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846076</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1140A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846090</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1340A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846113</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1540A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846205</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1050A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:43.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846212</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1150A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:42.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846236</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1350A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:42.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942127846250</udiDi>
    <basicUdiDi>697067138US046LT</basicUdiDi>
    <tradeName>Ureteral Access Sheath</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D1550A3S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:04:42.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937440443965</udiDi>
    <basicUdiDi>69368888BUGA012A</basicUdiDi>
    <tradeName>06937440443965</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang YiGao Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032913</manufacturerSrn>
    <authorisedRepresentativeName>TRANSMED GLOBAL CONSULTING, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000044598</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUG21060A-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:56:20.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937440443972</udiDi>
    <basicUdiDi>69368888BUGA012A</basicUdiDi>
    <tradeName>06937440443972</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang YiGao Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032913</manufacturerSrn>
    <authorisedRepresentativeName>TRANSMED GLOBAL CONSULTING, S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000044598</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUG25060A-EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:54:42.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349015144</udiDi>
    <basicUdiDi>081634901HydroUROE2</basicUdiDi>
    <tradeName>HiWire</tradeName>
    <deviceName>Guidewire: Hydrophilic  (Non-Vascular)</deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</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>HWS-038150-02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:57:30.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816349015137</udiDi>
    <basicUdiDi>081634901HydroUROE2</basicUdiDi>
    <tradeName>HiWire</tradeName>
    <deviceName>Guidewire: Hydrophilic  (Non-Vascular)</deviceName>
    <manufacturerName>Lake Region Medical</manufacturerName>
    <manufacturerSrn>US-MF-000033013</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>HWS-035150-02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:56:01.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250098847216</udiDi>
    <basicUdiDi>04250098810051EK</basicUdiDi>
    <tradeName>UROMED UROavenue Guide Wire</tradeName>
    <deviceName>GI01</deviceName>
    <manufacturerName>UROMED Kurt Drews KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006084</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0601</emdnCode>
    <emdnDescription>UROLOGICAL GUIDEWIRES, HYDROPHILIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:38:20.802Z</lastUpdated>
  </row>
</eudamedExport>