<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08593540509079</udiDi>
    <basicUdiDi>B-08593540509079</basicUdiDi>
    <tradeName>Cievka odsávacia s CO, 1 BO, 5,33mm (Ch 16) x 400 mm</tradeName>
    <deviceName>Cévka odsávací s CO, 1 BO, 5,33mm (Ch 16) x 400 mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646743-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:40:10.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540509048</udiDi>
    <basicUdiDi>B-08593540509048</basicUdiDi>
    <tradeName>Cievka odsávacia s CO, 1 BO, 4,67mm (Ch 14) x 400 mm</tradeName>
    <deviceName>Cévka odsávací s CO, 1 BO, 4,67mm (Ch 14) x 400 mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646742-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:40:06.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540509017</udiDi>
    <basicUdiDi>B-08593540509017</basicUdiDi>
    <tradeName>Cievka odsávacia s CO, 1 BO, 4mm (Ch 12) x 400 mm</tradeName>
    <deviceName>Cévka odsávací s CO, 1 BO, 4mm (Ch 12) x 400 mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646741-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:40:05.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508980</udiDi>
    <basicUdiDi>B-08593540508980</basicUdiDi>
    <tradeName>Cievka odsávacia s CO, 1 BO, 3,33mm (Ch 10) x 400 mm</tradeName>
    <deviceName>Cévka odsávací s CO, 1 BO, 3,33mm (Ch 10) x 400 mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646740-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:40:04.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508959</udiDi>
    <basicUdiDi>B-08593540508959</basicUdiDi>
    <tradeName>Cievka odsávacia s CO, 1 BO, 2,67mm (Ch 8) x 400 mm</tradeName>
    <deviceName>Cévka odsávací s CO, 1 BO, 2,67mm (Ch 8) x 400 mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646739-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:40:03.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508744</udiDi>
    <basicUdiDi>B-08593540508744</basicUdiDi>
    <tradeName>IRRIGATION-COOLING SET</tradeName>
    <deviceName>Irigační - chladící set</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040299</emdnCode>
    <emdnDescription>IRRIGATION KITS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606138-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:59.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508928</udiDi>
    <basicUdiDi>B-08593540508928</basicUdiDi>
    <tradeName>Cievka odsávacia s CO, 1 BO, 2mm (Ch 6) x 400 mm</tradeName>
    <deviceName>Cévka odsávací s CO, 1 BO, 2mm (Ch 6) x 400 mm</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646738-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:57.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508799</udiDi>
    <basicUdiDi>B-08593540508799</basicUdiDi>
    <tradeName>Cievka endobronchiálna CE-600</tradeName>
    <deviceName>Cévka endobronchiální CE-600</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R010499</emdnCode>
    <emdnDescription>ONE LUNG VENTILATION DEVICES (OLV) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606452-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:56.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508669</udiDi>
    <basicUdiDi>B-08593540508669</basicUdiDi>
    <tradeName>Prevodová súprava</tradeName>
    <deviceName>Převodová souprava</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040202</emdnCode>
    <emdnDescription>OCULAR IRRIGATION KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606386-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:55.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508621</udiDi>
    <basicUdiDi>B-08593540508621</basicUdiDi>
    <tradeName>Infúzna súprava IS-126 180 cm - 62 ShA</tradeName>
    <deviceName>Infúzní souprava IS-126 180 cm - 62 ShA</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606129-01ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:38.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508607</udiDi>
    <basicUdiDi>B-08593540508607</basicUdiDi>
    <tradeName>Infúzna súprava IS-126 - 62 ShA</tradeName>
    <deviceName>Infúzní souprava IS-126 - 62 ShA</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606126-01ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:38.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508447</udiDi>
    <basicUdiDi>B-08593540508447</basicUdiDi>
    <tradeName>Priming set dialyzačných súprav PS 003</tradeName>
    <deviceName>Priming set dialyzačních souprav PS 003</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F0304</emdnCode>
    <emdnDescription>DIALYSIS WASHING/FILLING KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606003-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:37.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508416</udiDi>
    <basicUdiDi>B-08593540508416</basicUdiDi>
    <tradeName>Cievka pre novorodenca s nízkou pôrodnou hmotnosťou CN-01</tradeName>
    <deviceName>Cévka pro novorozence s nízkou porodní hmotností CN-01</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V028002</emdnCode>
    <emdnDescription>NEONATOLOGY CARE KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646959-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:33.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508386</udiDi>
    <basicUdiDi>B-08593540508386</basicUdiDi>
    <tradeName>Cievka pupočná pre novorodenca CP-01</tradeName>
    <deviceName>Cévka pupeční pro novorozence CP-01</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V028002</emdnCode>
    <emdnDescription>NEONATOLOGY CARE KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646958-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:31.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508362</udiDi>
    <basicUdiDi>B-08593540508362</basicUdiDi>
    <tradeName>Cievka pre zavádzanie kyslíka nosovou cestou CK-472</tradeName>
    <deviceName>Cévka pro zavádění kyslíku nosní cestou CK-472</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R0301020301</emdnCode>
    <emdnDescription>OXYGEN THERAPY STANDARD NASAL CANNULAS (GOGGLES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V646956-ND</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:30.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508300</udiDi>
    <basicUdiDi>B-08593540508300</basicUdiDi>
    <tradeName>Transfúzna súprava pre krvné vaky TSV-221</tradeName>
    <deviceName>Transfúzní souprava pro krevní vaky TSV-221</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B010299</emdnCode>
    <emdnDescription>BLOOD TRANSFER BAGS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606221-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:28.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508263</udiDi>
    <basicUdiDi>B-08593540508263</basicUdiDi>
    <tradeName>Transfúzna súprava TS-204</tradeName>
    <deviceName>Transfúzní souprava TS-204</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B010299</emdnCode>
    <emdnDescription>BLOOD TRANSFER BAGS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606204-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:26.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508249</udiDi>
    <basicUdiDi>B-08593540508249</basicUdiDi>
    <tradeName>Transfúzna súprava TS-203</tradeName>
    <deviceName>Transfúzní souprava TS-203</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B010299</emdnCode>
    <emdnDescription>BLOOD TRANSFER BAGS AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606203-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:24.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508188</udiDi>
    <basicUdiDi>B-08593540508188</basicUdiDi>
    <tradeName>Oddeľovací filter</tradeName>
    <deviceName>Oddělovací filtr</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C03010104</emdnCode>
    <emdnDescription>EXTRACORPOREAL CIRCULATION FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606991-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:23.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>08593540508164</udiDi>
    <basicUdiDi>B-08593540508164</basicUdiDi>
    <tradeName>08593540508164</tradeName>
    <deviceName>GAMAPLUS POCARD</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A03020101</emdnCode>
    <emdnDescription>LOW PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606345-ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:39:22.057Z</lastUpdated>
  </row>
</eudamedExport>