BEUDAMED
    FDA Registration Active 🇸🇰 Slovakia

    Closed antineoplastic and hazardous drug reconstitution and transfer system

    Reg #: 3015462350 · FEI: 3015462350 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SKY Medical, a.s.
    Registration Number
    3015462350
    FEI Number
    3015462350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Vicenzy 24/2058
    City
    Samorin Trnavsky
    Country
    SK

    Regulatory Submissions

    510(k) Number
    K221513

    Owner / Operator

    Firm Name
    SKY Medical, a.s.
    Operator Number
    10060326
    Address
    Vicenzy 24/2058
    City
    Samorin
    State
    Trnavsky
    Postal Code
    931 01
    Country
    SK
    Correspondent
    Pavel Grinshpun

    US Agent

    Business Name
    ProMedic Consulting LLC
    Contact Name
    Matthew R. Dryden
    Address
    131 Bay Point Drive NE
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076063

    Products

    Device Name Product Code
    Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System ONB

    Proprietary Names

    Closed antineoplastic and hazardous drug reconstitution and transfer system

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)