<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14710961936326</udiDi>
    <basicUdiDi>B-14710961936326</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter</tradeName>
    <deviceName>Silicone Gastrostomy 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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:14:46.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961936319</udiDi>
    <basicUdiDi>B-14710961936319</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter</tradeName>
    <deviceName>Silicone Gastrostomy 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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:14:45.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961936289</udiDi>
    <basicUdiDi>B-14710961936289</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter</tradeName>
    <deviceName>Silicone Gastrostomy 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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0018</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:14:28.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961936272</udiDi>
    <basicUdiDi>B-14710961936272</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter</tradeName>
    <deviceName>Silicone Gastrostomy 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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:14:27.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961936265</udiDi>
    <basicUdiDi>B-14710961936265</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter</tradeName>
    <deviceName>Silicone Gastrostomy 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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:14:26.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>14710961936258</udiDi>
    <basicUdiDi>B-14710961936258</basicUdiDi>
    <tradeName>Silicone Gastrostomy Catheter</tradeName>
    <deviceName>Silicone Gastrostomy 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>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2019-0012</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:14:26.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521011311</udiDi>
    <basicUdiDi>B-10884521011311</basicUdiDi>
    <tradeName>10884521011311</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 20 Fr/Ch (6.7 mm) x 3.0 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>720300</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:38.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521011298</udiDi>
    <basicUdiDi>B-10884521011298</basicUdiDi>
    <tradeName>10884521011298</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 20 Fr/Ch (6.7 mm) x 2.5 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>720250</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:37.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521011267</udiDi>
    <basicUdiDi>B-10884521011267</basicUdiDi>
    <tradeName>10884521011267</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 20 Fr/Ch (6.7 mm) x 1.7 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>720170</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:36.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521011243</udiDi>
    <basicUdiDi>B-10884521011243</basicUdiDi>
    <tradeName>10884521011243</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 20 Fr/Ch (6.7 mm) x 1.0 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>720100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:35.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521011113</udiDi>
    <basicUdiDi>B-10884521011113</basicUdiDi>
    <tradeName>10884521011113</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 18 Fr/Ch (6.0 mm) x 1.2 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>718120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:31.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521010666</udiDi>
    <basicUdiDi>B-10884521010666</basicUdiDi>
    <tradeName>10884521010666</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 14 Fr/Ch (4.7 mm) x 2.0 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>714200</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:30.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521010635</udiDi>
    <basicUdiDi>B-10884521010635</basicUdiDi>
    <tradeName>10884521010635</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 14 Fr/Ch (4.7 mm) x 1.2 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>714120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:30.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521010628</udiDi>
    <basicUdiDi>B-10884521010628</basicUdiDi>
    <tradeName>10884521010628</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020203</emdnCode>
    <emdnDescription>ILEOSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>714100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:29.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521010512</udiDi>
    <basicUdiDi>B-10884521010512</basicUdiDi>
    <tradeName>10884521010512</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 12 Fr/Ch (4.0 mm) x 1.7 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>712170</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:25.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>10884521010475</udiDi>
    <basicUdiDi>B-10884521010475</basicUdiDi>
    <tradeName>10884521010475</tradeName>
    <deviceName>Kangaroo Skin Level Balloon Gastrostomy Kit, 12 Fr/Ch (4.0 mm) x 0.8 cm</deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-MF-000017721</manufacturerSrn>
    <authorisedRepresentativeName>Covidien Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002274</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>712080</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:24.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842071140786</udiDi>
    <basicUdiDi>08420711BALLOONBUTTON7U</basicUdiDi>
    <tradeName>MiniONE® Balloon Button - Low Profile Gastrostomy Feeding Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1-5-1412</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:02.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842071140960</udiDi>
    <basicUdiDi>08420711BALLOONBUTTON7U</basicUdiDi>
    <tradeName>MiniONE® Balloon Button - Low Profile Gastrostomy Feeding Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1-5-1440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:01.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842071140984</udiDi>
    <basicUdiDi>08420711BALLOONBUTTON7U</basicUdiDi>
    <tradeName>MiniONE® Balloon Button - Low Profile Gastrostomy Feeding Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1-5-1444</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:01.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842071141004</udiDi>
    <basicUdiDi>08420711BALLOONBUTTON7U</basicUdiDi>
    <tradeName>MiniONE® Balloon Button - Low Profile Gastrostomy Feeding Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Applied Medical Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041414</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M1-5-1450</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:01.811Z</lastUpdated>
  </row>
</eudamedExport>