BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    BREAST ARRAY COIL (Receive Only)

    Reg #: 3003768277 · FEI: 3002807880 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Registration Number
    3003768277
    FEI Number
    3002807880
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VEENPLUIS 6
    City
    BEST Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K961525

    Owner / Operator

    Firm Name
    Philips Medical Systems International BV
    Operator Number
    1217116
    Address
    Veenpluis 6
    City
    Best
    State
    NL-NOTA
    Postal Code
    5684PC
    Country
    NL

    US Agent

    Business Name
    Philips
    Contact Name
    Maria Heiling
    Address
    3721 Valley Centre Dr. Ste. 500
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US
    Email
    [email protected]
    Phone
    858 2487651

    Products

    Device Name Product Code
    Coil, Magnetic Resonance, Specialty MOS

    Proprietary Names

    BREAST ARRAY COIL (Receive Only) GE Excite HDe 1.5T 4CH (HDMR2-VALUE 4C OBC) GE 1.5T SIGNA 4C PA OBC GE Excite HD 1.5T 4 Channel Breast Coil GE 1T Signa 4CH OBC Breast Array Coil

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198