BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    CS-CU15-03

    Reg #: 3013348547 · FEI: 3013348547 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    CIPHER SURGICAL LTD
    Registration Number
    3013348547
    FEI Number
    3013348547
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    The Venture Centre, Sir William Lyons Road
    City
    Coventry
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K221824

    Owner / Operator

    Firm Name
    Cipher Surgical Ltd
    Operator Number
    10060194
    Address
    The Venture Centre, Sir William Lyons Road
    City
    Coventry
    State
    GB-COV
    Postal Code
    CV4 7EZ
    Country
    GB
    Correspondent
    Andrew Newell

    US Agent

    Business Name
    Medical Solutions Inc.
    Contact Name
    Manny Sok
    Address
    3901 Centerview Drive
    City
    Chantilly
    State
    VA
    ZIP
    20151
    Country
    US
    Email
    [email protected]
    Phone
    703 9957104

    Products

    Device Name Product Code
    Pump, Air, Non-Manual, For Endoscope FEQ
    Endoscopic Irrigation/Suction System OCX

    Proprietary Names

    CS-CU15-03 OpClear® Platform OpClear® Disposable Procedure Kit OpClear® Control Unit OpClear® Disposable OpClear® System OpClear®

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198