BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    UNISIS CORP.

    Reg #: 9681709 · FEI: 3003803331 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    9
    Establishment Types
    2
    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
    UNISIS CORP.
    Registration Number
    9681709
    FEI Number
    3003803331
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2675-1, Nishikata
    City
    Koshigaya-shi Saitama
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K142553

    Owner / Operator

    Firm Name
    UNISIS CORP.
    Operator Number
    9014974
    Address
    2675-1 Nishikata
    City
    Koshigaya-shi
    State
    Saitama
    Postal Code
    343-0822
    Country
    JP

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
    General Surgery Tray LRO
    Needle, Spinal, Short Term MIA
    Sampler, Amniotic Fluid (Amniocentesis Tray) HIO

    Proprietary Names

    UNIEVER Disposable Epidural Anesthesia Needle UNIEVER Disposable Nerve Blockade Needle UNIEVER Disposable Spinal Anesthesia Needle Needles, Paracenetsis Needle, Conduction, Anesthesia Unisis Needles, Lutz EchoGlo needles Needle, Conduction, Anesthetic

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)