<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>18586021477742</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH201520ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477759</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH201720ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477766</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH202020ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477773</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH202320ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477780</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH202520ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477797</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH202720ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477803</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH203020ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477810</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH203520ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477827</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH204020ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477834</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH204520ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477841</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH205020ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477858</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-SS0230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477865</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-SS0260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477872</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RY0230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477889</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RY0260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477896</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RS0230</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477902</udiDi>
    <basicUdiDi>602147EFSET4Y</basicUdiDi>
    <tradeName>Extension Feeding Set with ENFitTM connectors</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENTERAL NUTRITION KITS (INCLUDING THOSE VIA PUMP), SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EF-RS0260</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477919</udiDi>
    <basicUdiDi>602147IVSET9U</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IV-S30007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477926</udiDi>
    <basicUdiDi>602147CLSET5L</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-B12001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021477933</udiDi>
    <basicUdiDi>602147CLSET5L</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIGH PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-L18001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:31.602Z</lastUpdated>
  </row>
</eudamedExport>