BEUDAMED
    FDA Registration Active 🇫🇷 France

    Capsule Surveillance System

    Reg #: 3003630387 · FEI: 3003630387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Philips France
    Registration Number
    3003630387
    FEI Number
    3003630387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 rue Reaumur
    City
    PARIS
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K213335

    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
    Peter Kelley
    Address
    222 Jacobs Street
    City
    Cambridge
    State
    MA
    ZIP
    02141
    Country
    US
    Email
    [email protected]
    Phone
    978 6974364

    Products

    Device Name Product Code
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI

    Proprietary Names

    Capsule Surveillance System

    Establishment Types

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