BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Astra 300

    Reg #: 3006288727 · FEI: 3006288727 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SIBEL S.A.
    Registration Number
    3006288727
    FEI Number
    3006288727
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Raimon Casellas, 6-8.
    City
    Sabadell Barcelona
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K061571

    Owner / Operator

    Firm Name
    SIBEL S.A.
    Operator Number
    10046082
    Address
    Raimon Casellas, 6-8.
    City
    Sabadell
    State
    Barcelona
    Postal Code
    08205
    Country
    ES
    Correspondent
    Antoni Pico Genestar

    US Agent

    Business Name
    SDI Diagnostics, Inc.
    Contact Name
    Michael Boyle
    Address
    10 Hampden Drive
    City
    S Easton
    State
    MA
    ZIP
    02375
    Country
    US
    Email
    [email protected]
    Phone
    508 2387033

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    Astra 300

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)