BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Stryker

    Reg #: 3007189546 · FEI: 3007189546 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TAKUMI PRECISION ENGINEERING LTD
    Registration Number
    3007189546
    FEI Number
    3007189546
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Raheen Business Park, Raheen
    City
    Limerick
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K023087

    Owner / Operator

    Firm Name
    Takumi Precision Engineering Ltd
    Operator Number
    10043562
    Address
    Raheen Business Park, Raheen
    City
    Limerick
    State
    IE-LK
    Postal Code
    LK
    Country
    IE
    Correspondent
    Steve D Christopher

    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, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    Stryker

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)