BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    ORTEK AG

    Reg #: 3003061090 · FEI: 3003061090 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTEK AG
    Registration Number
    3003061090
    FEI Number
    3003061090
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    INDUSTRIE NORD 5
    City
    MERENSCHWAND Aargau
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K981451

    Owner / Operator

    Firm Name
    ORTEK AG
    Operator Number
    9064081
    Address
    INDUSTRIE NORD 5, --
    City
    MERENSCHWAND
    State
    Aargau
    Postal Code
    CH-5634
    Country
    CH
    Correspondent
    HANS - BACHMANN

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)