BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    W&H IMPEX INC.

    Reg #: 3007279848 · FEI: 3007279848 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    21

    Registration Details

    Registration Name
    W&H IMPEX INC.
    Registration Number
    3007279848
    FEI Number
    3007279848
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6490 Hawthorne Drive
    City
    Windsor Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K070663

    Owner / Operator

    Firm Name
    W&H Impex Inc.
    Operator Number
    10042701
    Address
    6490 Hawthorne Drive
    City
    Windsor
    State
    Ontario
    Postal Code
    N8T 1J9
    Country
    CA
    Correspondent
    Klaus Maier

    US Agent

    Business Name
    MEDAGENT Inc.
    Contact Name
    Franz Menean
    Address
    264 Lafayette Rd Ste 7
    City
    Portsmouth
    State
    NH
    ZIP
    03801
    Country
    US
    Email
    [email protected]
    Phone
    603 5702039

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB
    Instrument, Manual, Surgical, General Use MDM
    Handpiece, Direct Drive, Ac-Powered EKX
    Controller, Foot, Handpiece And Cord EBW
    Accessories, Implant, Dental, Endosseous NDP
    Scaler, Ultrasonic ELC
    Drill, Bone, Powered DZI
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Saw, Powered, And Accessories HAB
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bur, Surgical, General & Plastic Surgery GFF
    Cup, Prophylaxis EHK
    Handpiece, Rotary Bone Cutting KMW
    Motor, Surgical Instrument, Ac-Powered GEY
    Unit, Oral Irrigation EFS
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Catheter, Irrigation GBX
    Sterilizer, Steam FLE
    Tray, Surgical, Instrument FSM
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Instrument, Surgical, Sonic And Accessory/Attachment JDX

    Proprietary Names

    Instrument Set „BONE“ Foot Control Instrument Set “EXTRACTION” Instrument changer Instrument Set “ENDO” Instrument Set „PARO“ Instrument Set „SPECIAL“ Advanced Air System MN-111 LEXA Lexa PLUS RIS-311

    Establishment Types

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