BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Spectral Medical Inc.

    Reg #: 9617857 · FEI: 3000058367 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Spectral Medical Inc.
    Registration Number
    9617857
    FEI Number
    3000058367
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    135 The West Mall, Unit 2
    City
    TORONTO Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K183176

    Owner / Operator

    Firm Name
    Spectral Medical Inc.
    Operator Number
    9034643
    Address
    135 The West Mall, Unit 2
    City
    Toronto
    State
    Ontario
    Postal Code
    M9C 1C2
    Country
    CA
    Correspondent
    Narvin Ali

    US Agent

    Business Name
    Beaufort
    Contact Name
    Karin Hughes
    Address
    One Columbus Center, 283 Constitution Dr Ste 802
    City
    VAB
    State
    VA
    ZIP
    23462
    Country
    US
    Email
    [email protected]
    Phone
    757 3836025

    Products

    Device Name Product Code
    Assay, Endotoxin Activity, Chemiluminescent NGS
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG

    Proprietary Names

    EAA Smart Line TL Luminometer Sirius 2 Tube Luminometer

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device