<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08902120110886</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>FOLEY CATHETER 22FG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120110893</udiDi>
    <basicUdiDi>8902120A006RJ</basicUdiDi>
    <tradeName>FOLEY CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T20:54:01.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915502</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031414</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:26.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915496</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031412</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:25.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915489</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031410</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:24.183Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915472</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031310</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:22.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915465</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031308</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:21.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915458</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031306</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:20.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915441</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031218</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:19.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915434</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031216</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:18.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915427</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031214</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:17.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915410</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031212</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:15.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915403</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031210</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:14.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915397</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031208</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:13.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915380</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031118</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:12.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915373</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031116</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:11.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915366</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031114</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:09.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915359</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031112</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:08.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915342</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031110</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:07.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>06923310915335</udiDi>
    <basicUdiDi>69233109PU03PY</basicUdiDi>
    <tradeName>Nelaton Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Formed Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011212</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U01010502</emdnCode>
    <emdnDescription>NELATON CATHETERS, NON SELF-LUBRICATING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PU031108</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:09:06.228Z</lastUpdated>
  </row>
</eudamedExport>