BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SDI DIAGNOSTICS, INC.

    Reg #: 1220253 · FEI: 1220253 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    SDI DIAGNOSTICS, INC.
    Registration Number
    1220253
    FEI Number
    1220253
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10 Hampden Dr
    City
    South Easton
    State
    MA
    ZIP
    02375
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062913

    Owner / Operator

    Firm Name
    SDI DIAGNOSTICS, INC
    Operator Number
    1220253
    Address
    10 HAMPDEN DR., --
    City
    South Easton
    State
    MA
    Postal Code
    02375
    Country
    US

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG
    Filter, Bacterial, Breathing-Circuit CAH
    Mouthpiece, Breathing BYP

    Proprietary Names

    Astraguard, Filtrette, Filtrette A Bacterial Viral Filters Pulmoguard Safe-t-Check, Oval, Accurette, Air Tube Mouthpiece Spirobank Astra300 Diagnostic spirometer AstraTouch Diagnostic Spirometer Astra BT IQSense Spirometer Mouthpiece

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility