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    <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>GH185510BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.797Z</lastUpdated>
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    <udiDi>18586026081418</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>GH186010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.781Z</lastUpdated>
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    <udiDi>18586026081425</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>GH200810BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.763Z</lastUpdated>
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    <udiDi>18586026081432</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>GH201010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.743Z</lastUpdated>
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    <udiDi>18586026081449</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>GH201210BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.725Z</lastUpdated>
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    <udiDi>18586026082675</udiDi>
    <basicUdiDi>602147CMSET5T</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>CM-LS0150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.393Z</lastUpdated>
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    <udiDi>18586026082682</udiDi>
    <basicUdiDi>602147CMSET5T</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>CM-LS0005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.354Z</lastUpdated>
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    <udiDi>18586026082699</udiDi>
    <basicUdiDi>602147CMSET5T</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>CM-LS0008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.336Z</lastUpdated>
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    <udiDi>18586026082705</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-S90001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.315Z</lastUpdated>
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    <udiDi>18586026082712</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-S90002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.300Z</lastUpdated>
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    <udiDi>18586026082729</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-S90003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.272Z</lastUpdated>
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    <udiDi>18586026082736</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-S90004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.241Z</lastUpdated>
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    <udiDi>18586026082743</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-S90005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.219Z</lastUpdated>
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    <udiDi>18586026082750</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-S90006</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.199Z</lastUpdated>
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    <udiDi>18586026082767</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-D90001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.183Z</lastUpdated>
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    <udiDi>18586026082774</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-D90002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.167Z</lastUpdated>
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    <udiDi>18586026082781</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-D90003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.145Z</lastUpdated>
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    <udiDi>18586026082798</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-D90004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.127Z</lastUpdated>
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    <udiDi>18586026082804</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-T90001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.105Z</lastUpdated>
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    <udiDi>18586026082811</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-T90002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:13.090Z</lastUpdated>
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