BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Easy Control Micro Inserter

    Reg #: 8040449 · FEI: 3002501070 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OPHTEC BV
    Registration Number
    8040449
    FEI Number
    3002501070
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SCHWEITZERLAAN 15
    City
    GRONINGEN
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K011498

    Owner / Operator

    Firm Name
    OPHTEC USA
    Operator Number
    8040449
    Address
    400 sawgrass corporate pkwy
    City
    Sunrise
    State
    FL
    Postal Code
    33325
    Country
    US
    Correspondent
    Abraham Farhan

    Products

    Device Name Product Code
    Injector, Capsular Tension Ring NCE

    Proprietary Names

    Easy Control Micro Inserter StablEyes Capsular Tension Ring Inserter

    Establishment Types

    Manufacture Medical Device