BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIOSPHERE MEDICAL, S.A.

    Reg #: 9615728 · FEI: 3002808761 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    BIOSPHERE MEDICAL, S.A.
    Registration Number
    9615728
    FEI Number
    3002808761
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile, 95700 ROISSY-EN-FRANCE, FRANCE
    City
    Roissy Val-d'Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K010026

    Owner / Operator

    Firm Name
    Merit Medical Systems, Inc.
    Operator Number
    1721504
    Address
    1600 West Merit Parkway, --
    City
    South Jordan
    State
    UT
    Postal Code
    84095
    Country
    US

    US Agent

    Business Name
    MERIT MEDICAL SYSTEMS, INC
    Contact Name
    JOHN KNORPP
    Address
    1600 West Merit Parkway
    City
    South Jordan
    State
    UT
    ZIP
    84095
    Country
    US
    Email
    [email protected]
    Phone
    801 2084389

    Products

    Device Name Product Code
    Device, Neurovascular Embolization HCG
    Device, Vascular, For Promoting Embolization KRD
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY

    Proprietary Names

    EmboGold Microspheres EmboCube Gelatin Embolization Embosphere Microspheres QuadraSphere Q2 Microspheres QuadraSphere Microspheres Bearing nsPVA Embolization Particles Bearing nsPVA Express Torpedo Gelatin Foam

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)