<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942000243008</udiDi>
    <basicUdiDi>69420002044NB</basicUdiDi>
    <tradeName>Injection Needles</tradeName>
    <deviceName>Injection Needles</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHY-IN-23-230-2204-A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:53:06.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240939</udiDi>
    <basicUdiDi>B-06942000240939</basicUdiDi>
    <tradeName>Non-vascular Guidewire</tradeName>
    <deviceName>Non-vascular Guidewire</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G030899</emdnCode>
    <emdnDescription>INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHY-GW-88-350-A1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:53:05.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240878</udiDi>
    <basicUdiDi>69420002031N2</basicUdiDi>
    <tradeName>Disposable Grasping Forceps</tradeName>
    <deviceName>Disposable Grasping Forceps</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03050199</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHY-FG-18-230-A4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:53:02.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240786</udiDi>
    <basicUdiDi>69420002047NH</basicUdiDi>
    <tradeName>Non-vascular Guidewires</tradeName>
    <deviceName>Non-vascular Guidewires</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030899</emdnCode>
    <emdnDescription>INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHY-GW-88-215-A1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:59.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240755</udiDi>
    <basicUdiDi>B-06942000240755</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:56.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240724</udiDi>
    <basicUdiDi>B-06942000240724</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-19</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:55.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240694</udiDi>
    <basicUdiDi>B-06942000240694</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:53.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240663</udiDi>
    <basicUdiDi>B-06942000240663</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:49.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240632</udiDi>
    <basicUdiDi>B-06942000240632</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:47.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240601</udiDi>
    <basicUdiDi>B-06942000240601</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:46.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240571</udiDi>
    <basicUdiDi>B-06942000240571</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:43.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240540</udiDi>
    <basicUdiDi>B-06942000240540</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:40.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240519</udiDi>
    <basicUdiDi>B-06942000240519</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:37.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240489</udiDi>
    <basicUdiDi>B-06942000240489</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:36.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240458</udiDi>
    <basicUdiDi>B-06942000240458</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:34.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240427</udiDi>
    <basicUdiDi>B-06942000240427</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:30.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240397</udiDi>
    <basicUdiDi>B-06942000240397</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:28.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240366</udiDi>
    <basicUdiDi>B-06942000240366</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-09</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:26.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240335</udiDi>
    <basicUdiDi>B-06942000240335</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:24.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942000240304</udiDi>
    <basicUdiDi>B-06942000240304</basicUdiDi>
    <tradeName>Bougie Dilator Set</tradeName>
    <deviceName>Bougie Dilator Set</deviceName>
    <manufacturerName>Changzhou Jiuhong Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016791</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010201</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, PROGRESSIVE RIGID DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JHK-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:52:20.815Z</lastUpdated>
  </row>
</eudamedExport>