<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06948097054787</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054787</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054794</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054794</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054800</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054800</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054817</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054817</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054824</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054824</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054831</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054831</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054848</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054848</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054855</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054855</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054862</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054862</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06948097054893</udiDi>
    <basicUdiDi>6948097001DNGGN</basicUdiDi>
    <tradeName>06948097054893</tradeName>
    <deviceName>Urinary Catheters for Single Use (Foley)</deviceName>
    <manufacturerName>Haiyan Kangyuan Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001532</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:21.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961933380</udiDi>
    <basicUdiDi>B-04710961933380</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter Tiemann Tip</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1856-0220</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:36:08.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932390</udiDi>
    <basicUdiDi>B-04710961932390</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1824-0516</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:36:00.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961932376</udiDi>
    <basicUdiDi>B-04710961932376</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1824-0512</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:35:54.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>04710961931942</udiDi>
    <basicUdiDi>B-04710961931942</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1822-0526</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-24T21:35:53.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182628588</udiDi>
    <basicUdiDi>B-14711182628588</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter,Female</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1827-0014</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:23:04.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182628571</udiDi>
    <basicUdiDi>B-14711182628571</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter,Female</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1827-0016</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:23:03.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182628564</udiDi>
    <basicUdiDi>B-14711182628564</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter,Female</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1827-0018</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:23:02.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182628557</udiDi>
    <basicUdiDi>B-14711182628557</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter,Female</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1827-0020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:22:58.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182628540</udiDi>
    <basicUdiDi>B-14711182628540</basicUdiDi>
    <tradeName>Silicone 2-way Foley Balloon Catheter,Female</tradeName>
    <deviceName>Silicone 2-way Foley Balloon Catheter,Female</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1827-0022</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:22:58.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>14711182609051</udiDi>
    <basicUdiDi>B-14711182609051</basicUdiDi>
    <tradeName>SILICONE Foley Balloon Catheter</tradeName>
    <deviceName>SILICONE Foley Balloon Catheter</deviceName>
    <manufacturerName>FORTUNE MEDICAL INSTRUMENT CORP.</manufacturerName>
    <manufacturerSrn>TW-MF-000009221</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020299</emdnCode>
    <emdnDescription>URETERAL CATHETERS WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>65 20 20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:22:13.246Z</lastUpdated>
  </row>
</eudamedExport>