BEUDAMED
    FDA Registration Active 🇸🇮 Slovenia

    ISKRA MEDICAL D O O

    Reg #: 3007766590 · FEI: 3007766590 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ISKRA MEDICAL D O O
    Registration Number
    3007766590
    FEI Number
    3007766590
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Otoce 5a, Podnart
    City
    Podnart Radovljica
    Country
    SI

    Regulatory Submissions

    510(k) Number
    K083590

    Owner / Operator

    Firm Name
    ISKRA MEDICAL D O O
    Operator Number
    10029312
    Address
    STEGNE 3, Otoce 5a, 4244 Podnart
    City
    LJUBLJANA
    State
    SI-061
    Postal Code
    1000
    Country
    SI
    Correspondent
    PETER MAUCEC

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Cryo Derm Cryo Derm Prestige Green IRF Prestige and Accessories Green IRF LTF Prestige Green VAC VAC prestige Green VAC Exclusive LDT prestige

    Establishment Types

    Manufacture Medical Device