BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    HEBU

    Reg #: 9615857 · FEI: 3002409980 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INSTRUMENTARIUM SURGICAL CORP., INC.
    Registration Number
    9615857
    FEI Number
    3002409980
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1273 Rue Saint-Louis
    City
    TERREBONNE Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K182812

    Owner / Operator

    Firm Name
    INSTRUMENTARIUM SURGICAL CORP., INC.
    Operator Number
    9041885
    Address
    1273 RUE SAINT-LOUIS, --
    City
    TERREBONNE
    State
    Quebec
    Postal Code
    J6W 1K6
    Country
    CA
    Correspondent
    JEAN-PAUL - DAVID

    US Agent

    Business Name
    Pragmatic Compliance dba FDAbasics
    Contact Name
    Jerry Doane
    Address
    15815 SW 11th Court Rd
    City
    Ocala
    State
    FL
    ZIP
    34473
    Country
    US
    Email
    [email protected]
    Phone
    716 7750533

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    HEBU

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device