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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>MDR 2017/745</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH182720BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T18:45:23.593Z</lastUpdated>
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    <udiDi>18586026082248</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>MDR 2017/745</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH183020BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T18:45:23.528Z</lastUpdated>
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    <udiDi>04542187172621</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>PEG REPLACEMENT WITH ENFIT CONNECTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002-265-0140</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.831Z</lastUpdated>
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    <udiDi>04542187172638</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>PEG REPLACEMENT WITH ENFIT CONNECTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002-265-0160</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.815Z</lastUpdated>
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    <udiDi>04542187172645</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>PEG REPLACEMENT WITH ENFIT CONNECTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>002-265-0180</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.802Z</lastUpdated>
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    <udiDi>04542187172652</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>PEG REPLACEMENT WITH ENFIT CONNECTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-000-1985</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.790Z</lastUpdated>
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    <udiDi>04542187172669</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>PEG REPLACEMENT WITH ENFIT CONNECTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-000-1986</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.773Z</lastUpdated>
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    <udiDi>04542187172676</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>PEG REPLACEMENT WITH ENFIT CONNECTOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-000-1987</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.756Z</lastUpdated>
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    <udiDi>04542187173277</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-000-2162</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.712Z</lastUpdated>
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    <udiDi>04542187173284</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-000-2163</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.702Z</lastUpdated>
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    <udiDi>04542187173291</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-000-2164</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.690Z</lastUpdated>
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    <udiDi>04542187173307</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-000-2165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.682Z</lastUpdated>
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    <udiDi>04542187173314</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-000-2166</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.673Z</lastUpdated>
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    <udiDi>04542187173321</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-000-2167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.662Z</lastUpdated>
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    <udiDi>04542187173338</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>All Silicone Gastrostomy Balloon Catheter for Replacement, Flat Balloon Type</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>800-000-2168</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:55.654Z</lastUpdated>
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    <udiDi>04542187194579</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>Silikon-Gastrostomie-Ersatz-Ballonzonde (Frachballon Type) mit rechtwinkliger externer Halteplatte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN800-000-2163R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:36.505Z</lastUpdated>
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    <udiDi>04542187194586</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>Silikon-Gastrostomie-Ersatz-Ballonzonde (Frachballon Type) mit rechtwinkliger externer Halteplatte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN800-000-2164R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:36.496Z</lastUpdated>
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    <udiDi>04542187194593</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>Silikon-Gastrostomie-Ersatz-Ballonzonde (Frachballon Type) mit rechtwinkliger externer Halteplatte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN800-000-2165R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:36.484Z</lastUpdated>
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    <udiDi>04542187194609</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>Silikon-Gastrostomie-Ersatz-Ballonzonde (Frachballon Type) mit rechtwinkliger externer Halteplatte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN800-000-2166R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:36.469Z</lastUpdated>
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    <udiDi>04542187194616</udiDi>
    <basicUdiDi>45421870000893</basicUdiDi>
    <tradeName>Silikon-Gastrostomie-Ersatz-Ballonzonde (Frachballon Type) mit rechtwinkliger externer Halteplatte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CREATE MEDIC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010849</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G02020201</emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN800-000-2167R</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:36.451Z</lastUpdated>
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