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    <tradeName>Urodynamická súprava malá USM - 1845 mm</tradeName>
    <deviceName>Urodynamická souprava malá USM - 1845 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>U0599</emdnCode>
    <emdnDescription>URODYNAMICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606481-02ND</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:33.969Z</lastUpdated>
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    <basicUdiDi>B-08593540506955</basicUdiDi>
    <tradeName>Rampa 5cestná s BV NO PVC</tradeName>
    <deviceName>Rampa 5cestná s BV NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0702</emdnCode>
    <emdnDescription>RAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696425</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:32.379Z</lastUpdated>
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    <basicUdiDi>B-08593540506931</basicUdiDi>
    <tradeName>Rampa 3cestná s BV NO PVC</tradeName>
    <deviceName>Rampa 3cestná s BV NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0702</emdnCode>
    <emdnDescription>RAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696423</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:31.555Z</lastUpdated>
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    <basicUdiDi>B-08593540506726</basicUdiDi>
    <tradeName>Bezihlový vstup - červený</tradeName>
    <deviceName>Bezjehlový vstup - červený</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A070199</emdnCode>
    <emdnDescription>ADAPTERS AND CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696421</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:29.958Z</lastUpdated>
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    <udiDi>08593540506580</udiDi>
    <basicUdiDi>B-08593540506580</basicUdiDi>
    <tradeName>SKALA OK3-V3 Perfusion set</tradeName>
    <deviceName>SKALA OK3-V3 Lavážní 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>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606501-03</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:27.554Z</lastUpdated>
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    <udiDi>08593540506511</udiDi>
    <basicUdiDi>B-08593540506511</basicUdiDi>
    <tradeName>Trojcestný kohút - biely NO PVC</tradeName>
    <deviceName>Trojcestný kohout - bílý NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696442</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:25.949Z</lastUpdated>
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    <udiDi>08593540506320</udiDi>
    <basicUdiDi>B-08593540506320</basicUdiDi>
    <tradeName>Rampa 5 kohútov NO PVC</tradeName>
    <deviceName>Rampa 5 kohoutů NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0702</emdnCode>
    <emdnDescription>RAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696437</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:25.151Z</lastUpdated>
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    <udiDi>08593540506306</udiDi>
    <basicUdiDi>B-08593540506306</basicUdiDi>
    <tradeName>Rampa 3 kohúty NO PVC</tradeName>
    <deviceName>Rampa 3 kohouty NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0702</emdnCode>
    <emdnDescription>RAMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696436</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:23.556Z</lastUpdated>
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    <udiDi>08593540506276</udiDi>
    <basicUdiDi>B-08593540506276</basicUdiDi>
    <tradeName>Trojcestný kohút - modrý NO PVC</tradeName>
    <deviceName>Trojcestný kohout - modrý NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696435</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:21.146Z</lastUpdated>
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    <udiDi>08593540506245</udiDi>
    <basicUdiDi>B-08593540506245</basicUdiDi>
    <tradeName>Trojcestný kohút - červený NO PVC</tradeName>
    <deviceName>Trojcestný kohout - červený NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696434</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:19.575Z</lastUpdated>
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    <udiDi>08593540506214</udiDi>
    <basicUdiDi>B-08593540506214</basicUdiDi>
    <tradeName>Bezpečnostný uzáver NO PVC</tradeName>
    <deviceName>Bezpečnostní uzávěr NO PVC</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A070199</emdnCode>
    <emdnDescription>ADAPTERS AND CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696433</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:18.755Z</lastUpdated>
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    <udiDi>08593540505712</udiDi>
    <basicUdiDi>B-08593540505712</basicUdiDi>
    <tradeName>Bezihlový vstup</tradeName>
    <deviceName>Bezjehlový vstup</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A070199</emdnCode>
    <emdnDescription>ADAPTERS AND CONNECTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V696420</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:17.154Z</lastUpdated>
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    <udiDi>08593540505675</udiDi>
    <basicUdiDi>B-08593540505675</basicUdiDi>
    <tradeName>SKALA OK3-V2 Perfusion set</tradeName>
    <deviceName>SKALA OK3-V2 Lavážní 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>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606501-02</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:14.749Z</lastUpdated>
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    <udiDi>08593540505651</udiDi>
    <basicUdiDi>B-08593540505651</basicUdiDi>
    <tradeName>SKALA OK3-V1 Perfusion set</tradeName>
    <deviceName>SKALA OK3-V1 Lavážní 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>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606501-01</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:13.146Z</lastUpdated>
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    <basicUdiDi>B-08593540505545</basicUdiDi>
    <tradeName>SKALA OK3 Perfusion set</tradeName>
    <deviceName>SKALA OK3 Lavážní 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>V80</emdnCode>
    <emdnDescription>CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606501</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:12.349Z</lastUpdated>
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    <udiDi>08593540500441</udiDi>
    <basicUdiDi>B-08593540500441</basicUdiDi>
    <tradeName>Infúzna súprava IS-123</tradeName>
    <deviceName>Infúzní souprava IS-123</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>V606123</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:11.700Z</lastUpdated>
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    <basicUdiDi>B-08593540500403</basicUdiDi>
    <tradeName>Infúzna súprava IS-121</tradeName>
    <deviceName>Infúzní souprava IS-121</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>A03040199</emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V606121</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:08.387Z</lastUpdated>
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    <basicUdiDi>B-08593540408877</basicUdiDi>
    <tradeName>Zkumavka 15 ccm PS - sterilní bez zátky VB</tradeName>
    <deviceName>Zkumavka 15 ccm PS - sterilní bez zátky VB</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W050301020102</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V400565</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:06.750Z</lastUpdated>
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    <basicUdiDi>B-08593540408846</basicUdiDi>
    <tradeName>Petriho miska Ø 90 mm sterilní - R - EN</tradeName>
    <deviceName>Petriho miska Ø 90 mm sterilní - R - EN</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0503030101</emdnCode>
    <emdnDescription>PETRI DISHES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V400994-EN</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:05.933Z</lastUpdated>
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    <basicUdiDi>B-08593540408792</basicUdiDi>
    <tradeName>Zkumavka 15 ccm PS - sterilní - zelená zátka</tradeName>
    <deviceName>Zkumavka 15 ccm PS - sterilní - zelená zátka</deviceName>
    <manufacturerName>GAMA GROUP a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011894</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W050301020102</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC TUBES WITHOUT ADDITIVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V400915-54</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:38:04.332Z</lastUpdated>
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