BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    CoLink PCR Plating System

    Reg #: 3007791110 · FEI: 3007791110 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INVIBIO DEVICE COMPONENT MANUFACTURING, LTD. (IDCM LTD.)
    Registration Number
    3007791110
    FEI Number
    3007791110
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hillhouse International
    City
    Thornton Cleveleys Lancashire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K213698

    Owner / Operator

    Firm Name
    Invibio Device Component Manufacturing, Ltd. (IDCM Ltd.)
    Operator Number
    10085461
    Address
    Hillhouse International
    City
    Thornton Cleveleys
    State
    Lancashire
    Postal Code
    FY5 4QD
    Country
    GB
    Correspondent
    Caroline Prisk

    US Agent

    Business Name
    Invibio
    Contact Name
    Michael Wallick
    Address
    300 Conshohocken St Rd, Suite 120
    City
    Conshohocken
    State
    PA
    ZIP
    19428
    Country
    US
    Email
    [email protected]
    Phone
    484 3426051

    Products

    Device Name Product Code
    Plate, Fixation, Bone HRS

    Proprietary Names

    CoLink PCR Plating System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)