BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate,

    Reg #: 3003768277 · FEI: 3002807880 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    37
    Establishment Types
    2
    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
    K032576

    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

    Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate, GE Excite 1.5T 7Ch Biopsy Breast Array Siemens SYMPHONY 1.5T BBC Fiducial Holder, Needle Hub Assembly, LBS 3T SMS 7 ch Siemens Luminescence 1.5T Breast Coil 7 Ch GE HDx 3T 7Ch Biopsy Breast PHILIPS 1.5T INTERA ACHIEVA (CDAS) BBC GE Excite HDx 1.5T 7ch BBC GE LBS 3T 16CH MammoTrak Interventional Breast Coil 1.5T Philips dS Breast 7ch 1.5T HITACHI 1.5T 7C BREAST Coil/ASM/Breast Coil for Echelon Philips dS Breast 7ch 3T GE Excite 1.5T 7CH BBC Siemens AVANTO 1.5T BBC Grid Immobilization Plate LBS, Pillar Immobilization Plate LBS, Needle Block Holder, Toshiba 1.5T 7Ch BBC Siemens Luminescence 1.5T Breast Coil 16 Ch Biopsy Breast Coil GE LBS 3T 7CH Philips 7ch SENSE Breast Coil 1.5T GE Excite HDx 1.5T HDx 7CH BBC Siemens Luminescence 3T Breast Coil 16 Ch Siemens 1.5T Symphony 7Ch BBC (Breast Biopsy Coil) GE LBS 1.5T16CH Philip Interventional Coil 3T, PHC, Achieva TX Toshiba 1.5T 7CH BBC dS Breast 16ch 1.5T dS Breast 7ch 1.5T dS Breast 7ch 3T Achieva TX Interventional Coil 3T AVANTO BIOPSY BREAST ARRAY Mammotrak Interventional Coil 1.5T SENSE Breast Coil 7ch BREAST SPEEDER

    Establishment Types

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