BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    OSSTELL AB

    Reg #: 3004070020 · FEI: 3004070020 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OSSTELL AB
    Registration Number
    3004070020
    FEI Number
    3004070020
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Stampgaten 14
    City
    GOTEBORG Vastra Gotaland
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K142358

    Owner / Operator

    Firm Name
    OSSTELL AB
    Operator Number
    9059818
    Address
    Stampgaten 14, --
    City
    GOTEBORG
    State
    SE-NOTA
    Postal Code
    41101
    Country
    SE
    Correspondent
    Stellan - Sundstrom

    US Agent

    Business Name
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX
    Medical Device Data System OUG

    Proprietary Names

    Smart Pegs Type 1-111 SmartPeg Type 117, 127, 137 OsstellConnect SmartPeg Types 1- 111 Mega ISQ II Beacon Smart Pegs Type 1- 115 ISQTracker NeoTell, Osstell Classic

    Establishment Types

    Manufacture Medical Device