<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>24710961934848</udiDi>
    <basicUdiDi>B-24710961934848</basicUdiDi>
    <tradeName>Silicone C.W.V. Reservoir</tradeName>
    <deviceName>Silicone C.W.V. Reservoir</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 I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0601010199</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2013-0615</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:41:26.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>18961104264288</udiDi>
    <basicUdiDi>B-18961104264288</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>SUC,TIP,ENT,4MM</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16-745-01BK</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:05:54.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>18961104260112</udiDi>
    <basicUdiDi>B-18961104260112</basicUdiDi>
    <tradeName>Wrangler Instruments</tradeName>
    <deviceName>Tube suction,Yankauer,270mm</deviceName>
    <manufacturerName>Wrangler Instruments</manufacturerName>
    <manufacturerSrn>PK-MF-000009409</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16-150-27UN</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:00:08.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526136525</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP808-313815 High Vacuum Pipeline suction controller on a direct BS probe and the collection jar on a universal rail clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010201</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP808-313815</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:18:08.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526136532</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP826-311215 Low Vacuum Pipeline suction controller and collection jar both mounted on a standard rail clamp, 2m hose and remote BS vacuum probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010201</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP826-311215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:18:08.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526136549</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP828-313815 Low Vacuum Pipeline auction controller on a direct BS vacuum probe, collection jar on a universal rail clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010201</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP828-313815</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:18:08.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526136556</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP846-311215 Thoracic suction controller and collection jar both on standard rail clamps, 1m hose and remote BS vacuum probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010201</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP846-311215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:18:08.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526136563</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP848-313815 Thoracic suction controller on a direct BS vacuum probe, collection jar on a universal rail clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010201</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP848-313815</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:18:07.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526136570</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSR430-811510 High vacuum injector suction controller with gauge and disposable bacterial filter on a direct BS type probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A0601010201</emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSR430-811510</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:18:07.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606250</udiDi>
    <basicUdiDi>B-16945934606250</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR08 middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:23.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606243</udiDi>
    <basicUdiDi>B-16945934606243</basicUdiDi>
    <tradeName>Suction catheter, funnel type</tradeName>
    <deviceName>Suction catheter, funnel type</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR10N middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:22.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606236</udiDi>
    <basicUdiDi>B-16945934606236</basicUdiDi>
    <tradeName>suction catheter, funnel type</tradeName>
    <deviceName>suction catheter, funnel type</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR06N middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:21.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606229</udiDi>
    <basicUdiDi>B-16945934606229</basicUdiDi>
    <tradeName>Suction catheter, funnel type</tradeName>
    <deviceName>Suction catheter, funnel type</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR08N middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:17.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606076</udiDi>
    <basicUdiDi>B-16945934606076</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR18 middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:16.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606069</udiDi>
    <basicUdiDi>B-16945934606069</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C02-10 middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:15.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606052</udiDi>
    <basicUdiDi>B-16945934606052</basicUdiDi>
    <tradeName>suction catheter</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR06 middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:15.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934606045</udiDi>
    <basicUdiDi>B-16945934606045</basicUdiDi>
    <tradeName>Suction catheter, funnel type</tradeName>
    <deviceName>Suction catheter, funnel type</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR18N middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:11.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934605239</udiDi>
    <basicUdiDi>B-16945934605239</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR16 middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:03.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934605222</udiDi>
    <basicUdiDi>B-16945934605222</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR14 middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:03.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945934605215</udiDi>
    <basicUdiDi>B-16945934605215</basicUdiDi>
    <tradeName>Suction catheter, funnel type, with side holes</tradeName>
    <deviceName>Suction catheter, funnel type, with side holes</deviceName>
    <manufacturerName>Changzhou Huankang Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009030</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A06010103</emdnCode>
    <emdnDescription>CANNULAS AND TIPS FOR ASPIRATION AND IRRIGATION, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK-C01-03-FR12 middle box</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:07:02.286Z</lastUpdated>
  </row>
</eudamedExport>