BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Sirius Pintuition Seed 7cm

    Reg #: 3020733550 · FEI: 3020733550 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SIRIUS MEDICAL SYSTEMS B.V.
    Registration Number
    3020733550
    FEI Number
    3020733550
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    High Tech Campus 41
    City
    Eindhoven Noord-Brabant
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K223682

    Owner / Operator

    Firm Name
    Sirius Medical Systems B.V.
    Operator Number
    10082996
    Address
    High Tech Campus 41
    City
    Eindhoven
    State
    Noord-Brabant
    Postal Code
    5656AE
    Country
    NL
    Correspondent
    Bram Schermers

    Products

    Device Name Product Code
    Temporary Tissue Marker PBY
    Marker, Radiographic, Implantable NEU

    Proprietary Names

    Sirius Pintuition Seed 7cm Sirius Pintuition Probe Sirius Pintuition Slim Probe Sirius Pintuition Base Unit Sirius Pintuition Seed 12cm Sirius Pintuition Slim Test Kit Sirius Pintuition Test Kit

    Establishment Types

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