BEUDAMED
    EU Manufacturer 🇨🇿 Czechia Active

    GAMA GROUP a.s.

    SRN: CZ-MF-000011894 · Mánesova 11/3b, 37001 České Budějovice, Czechia
    View on EUDAMED
    Basic UDI-DIs
    164
    Total Devices
    200
    On Market
    200
    Off Market
    0
    Certificates
    9
    Valid
    1
    Expiring < 6mo
    0
    Countries
    9

    Basic Information

    Address
    Mánesova 11/3b, 37001 České Budějovice, Czechia
    Email
    [email protected]

    Regulatory Overview

    Regulation
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    Eu Mdd 151
    Eu Ivdr 7
    Eu Mdr 6
    Classification
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    Eu Md Class 2a 140
    Eu Md Class 1 17
    Eu Ivd Class A 7
    Device Types
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    Certificate Health

    Total
    9
    Valid
    1
    Expiring < 6mo
    0
    Expired / Withdrawn
    8
    Certificates by Expiry Year
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    Type Number Expiry Date Status
    MDD Annex II Section 4 MED 210006 May 25, 2024
    MDD Annex II Section 4 MED 210010 May 25, 2024
    MDD Annex II Section 4 MED 210008 May 25, 2024
    MDD Annex V MED 210005 May 26, 2024
    MDD Annex V MED 210004 May 26, 2024
    MDD Annex II Section 4 MED 210012 May 26, 2024
    MDD Annex II Section 4 MED 210013 May 26, 2024
    MDD Annex II Section 4 MED 210009 May 26, 2024
    MDR QMS 23 0517 QR/NB Nov 09, 2028 Issued

    Market Presence

    Devices from this manufacturer are available in 9 countries across Europe.

    🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇭🇺 Hungary 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇸🇮 Slovenia 🇸🇰 Slovakia

    Device Portfolio

    Name
    ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES
    Bezihlový vstup
    Bezihlový vstup - červený
    Bezpečnostný uzáver NO PVC
    Cievka Nelaton s 2 BO, M, 2,67mm (Ch 8) x 400 mm
    Cievka Nelaton s 2 BO, M, 4,67mm (Ch 14) x 400 mm
    Cievka Nelaton s 2 BO, M, 4mm (Ch 12) x 400 mm
    Cievka Nelaton s 2 BO, M, 5,33mm (Ch 16) x 400 mm
    Cievka Nelaton s 2 BO, M, 6,67mm (Ch 20) x 400 mm
    Cievka Nelaton s 2 BO, M, 6mm (Ch 18) x 400 mm
    Cievka Nelaton s 2 BO, M, 7,33mm (Ch 22) x 400 mm
    Cievka Nelaton s 2 BO, T, 2,67mm (Ch 8) x 400 mm
    Cievka Nelaton s 2 BO, T, 3,33mm (Ch 10) x 400 mm
    Cievka Nelaton s 2 BO, T, 4,67mm (Ch 14) x 400 mm
    Cievka Nelaton s 2 BO, T, 4mm (Ch 12) x 400 mm
    Cievka Nelaton s 2 BO, T, 5,33mm (Ch 16) x 400 mm
    Cievka Nelaton s 2 BO, T, 6,67mm (Ch 20) x 400 mm
    Cievka Nelaton s 2 BO, T, 6mm (Ch 18) x 400 mm
    Cievka Nelaton s 2 BO, T, 7,33mm (Ch 22) x 400 mm
    Cievka Nelaton s 2 BO, T, 8,3mm (Ch 25) x 400 mm
    Cievka Redon 28 otvorov, 3,33mm (Ch 10) x 700 mm
    Cievka Redon 28 otvorov, 4,67mm (Ch 14) x 1200 mm
    Cievka Redon 28 otvorov, 4mm (Ch 12) x 1200 mm
    Cievka Redon 28 otvorov, 5,33mm (Ch 16) x 1200 mm
    Cievka Redon 28 otvorov, 5,33mm (Ch 16) x 500 mm
    Cievka Redon 28 otvorov, 6mm (Ch 18) x 1200 mm
    Cievka Redon 28 otvorov, 6mm (Ch 18) x 500 mm
    Cievka Redon 336 otvorov, 3,33mm (Ch 10) x 1200 mm
    Cievka Redon 56 otvorov, 3,33mm (Ch 10) x 700 mm
    Cievka Redon 56 otvorov, 4mm (Ch 12) x 1200 mm
    Cievka Tiemann s 2 BO, 2,67mm (Ch 8) x 400, M
    Cievka Tiemann s 2 BO, 2,67mm (Ch 8) x 400, T
    Cievka Tiemann s 2 BO, 3,33mm (Ch 10) x 400, M
    Cievka Tiemann s 2 BO, 3,33mm (Ch 10) x 400, T
    Cievka Tiemann s 2 BO, 4,67mm (Ch 14) x 400, M
    Cievka Tiemann s 2 BO, 4,67mm (Ch 14) x 400, T
    Cievka Tiemann s 2 BO, 4mm (Ch 12) x 400, M
    Cievka Tiemann s 2 BO, 4mm (Ch 12) x 400, T
    Cievka Tiemann s 2 BO, 5,33mm (Ch 16) x 400, M
    Cievka Tiemann s 2 BO, 5,33mm (Ch 16) x 400, T
    Cievka Tiemann s 2 BO, 6,67mm (Ch 20) x 400, M
    Cievka Tiemann s 2 BO, 6,67mm (Ch 20) x 400, T
    Cievka Tiemann s 2 BO, 6mm (Ch 18) x 400, M
    Cievka Tiemann s 2 BO, 6mm (Ch 18) x 400, T
    Cievka Tiemann s 2 BO, 7,33mm (Ch 22) x 400, M
    Cievka Tiemann s 2 BO, 7,33mm (Ch 22) x 400, T
    Cievka endobronchiálna CE-600
    Cievka odsávacia s CO, 1 BO, 2,67mm (Ch 8) x 400 mm
    Cievka odsávacia s CO, 1 BO, 2mm (Ch 6) x 400 mm
    Cievka odsávacia s CO, 1 BO, 3,33mm (Ch 10) x 400 mm
    View all 200 devices →