BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Gyrus ACMI, Inc.

    Reg #: 3004450998 · FEI: 3004450998 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Gyrus ACMI, Inc.
    Registration Number
    3004450998
    FEI Number
    3004450998
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6675 185th Avenue NE
    City
    Redmond
    State
    WA
    ZIP
    98052
    Country
    US

    Regulatory Submissions

    PMA Number
    H060002

    Owner / Operator

    Firm Name
    OLYMPUS CORPORATION
    Operator Number
    9067818
    Address
    2951 ISHIKAWA-CHO
    City
    HACHIOJI-SHI
    State
    Tokyo
    Postal Code
    192-8507
    Country
    JP

    Products

    Device Name Product Code
    One-Way Air-Leak Valve OAZ
    Valve, Pulmonary NJK

    Proprietary Names

    IBV Valve IBV Valve System

    Establishment Types

    Manufacture Medical Device