BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    EMBLATION LIMITED

    Reg #: 3010933564 · FEI: 3010933564 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    EMBLATION LIMITED
    Registration Number
    3010933564
    FEI Number
    3010933564
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Emblation House, Castle Business Park
    City
    Stirling
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K181941

    Owner / Operator

    Firm Name
    Emblation Limited
    Operator Number
    10048070
    Address
    Emblation House, Castle Business Park
    City
    Stirling
    State
    GB-STG
    Postal Code
    FK9 4TS
    Country
    GB
    Correspondent
    Mairi MacFadyen

    US Agent

    Business Name
    Judy Snow & Associates
    Contact Name
    Judy Snow
    Address
    1944 5th Ct Se
    City
    Vero Beach
    State
    FL
    ZIP
    32962
    Country
    US
    Email
    [email protected]
    Phone
    508 9589532

    Products

    Device Name Product Code
    System, Ablation, Microwave And Accessories NEY

    Proprietary Names

    Swift® System swiftPro Emprint Ablation System with Thermosphere Technology

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device