BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Waismed Ltd.

    Reg #: 9616791 · FEI: 3001316486 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    Waismed Ltd.
    Registration Number
    9616791
    FEI Number
    3001316486
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Amal St., Afek Industrial Park
    City
    Rosh Haayin Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K022415

    Owner / Operator

    Firm Name
    Safeguard US Operating LLC
    Operator Number
    9024805
    Address
    13359 Reese Blvd. E.
    City
    Huntersville
    State
    NC
    Postal Code
    28078
    Country
    US
    Correspondent
    Kimberly - Reed

    US Agent

    Business Name
    Safeguard US Operating
    Contact Name
    Kimberly Reed
    Address
    13359 Reese Blvd. E
    City
    Huntersville
    State
    NC
    ZIP
    28078
    Country
    US
    Email
    [email protected]
    Phone
    855 4286074

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI
    Needle, Interosseous MHC
    Device, Intravascular Catheter Securement KMK
    Intravenous Extension Tubing Set OJA
    Tourniquet, Nonpneumatic GAX

    Proprietary Names

    B.I.G. Pediatric B.I.G NIO Adult NIO Infant NIO Fixation B.I.G. Adult NIO Pediatric GO-IO NIO+ Adult Secure IV

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device