BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ZENITH 11 MEDICAL LLC

    Reg #: 3031282706 · FEI: 3031282706 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    ZENITH 11 MEDICAL LLC
    Registration Number
    3031282706
    FEI Number
    3031282706
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    99198 Overseas Hwy, Ste 12
    City
    Key Largo
    State
    FL
    ZIP
    33037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222182

    Owner / Operator

    Firm Name
    Zenith 11 Medical LLC
    Operator Number
    10090757
    Address
    99198 Overseas Hwy, Ste 12
    City
    Key Largo
    State
    FL
    Postal Code
    33037
    Country
    US
    Correspondent
    Parth Patel

    Products

    Device Name Product Code
    Board, Arm (With Cover), Non-Sterile NOD
    Clamp, Vascular DXC
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Introducer, Catheter DYB

    Proprietary Names

    ARM SUPPORT BOARD Radial Artery Compression Tourniquets Push Click Y Connector Kit INTRODUCER SHEATH KITS RADIAL

    Establishment Types

    Repack or Relabel Medical Device