BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    ENDOMAGNETICS LTD

    Reg #: 3012644426 · FEI: 3012644426 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    ENDOMAGNETICS LTD
    Registration Number
    3012644426
    FEI Number
    3012644426
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    330 Cambridge Science Park, Milton Road
    City
    Cambridge Cambridgeshire
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K232865
    PMA Number
    P160053

    Owner / Operator

    Firm Name
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Sue Dahlquist

    US Agent

    Business Name
    Emergo Global Consulting LLC
    Contact Name
    Greg Swanson
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Marker, Radiographic, Implantable NEU
    Temporary Tissue Marker PBY
    Lymph Node Location System During Sentinel Biopsy Procedure PUV
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN

    Proprietary Names

    Magseed Pro Magseed Magtrace Sentimag Cart

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility