BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    NDD MEDIZINTECHNIK AG

    Reg #: 9614485 · FEI: 3002673652 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    16
    Establishment Types
    3
    Classifications
    5

    Registration Details

    Registration Name
    NDD MEDIZINTECHNIK AG
    Registration Number
    9614485
    FEI Number
    3002673652
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    TECHNOPARKSTRASSE 1
    City
    ZURICH
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K230178

    Owner / Operator

    Firm Name
    ndd Medizintechnik AG
    Operator Number
    9040235
    Address
    Technoparkstrasse 1
    City
    Zurich
    State
    CH-ZH
    Postal Code
    CH-8005
    Country
    CH
    Correspondent
    Roman M Eicher

    US Agent

    Business Name
    ndd Medical Technologies
    Contact Name
    Joy Tobin
    Address
    300 Brickstone Square, Suite 604
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 4700923 ext. 124

    Products

    Device Name Product Code
    Transducer, Gas Flow BXP
    Spirometer, Diagnostic BZG
    Calculator, Predicted Values, Pulmonary Function BTY
    Filter, Bacterial, Breathing-Circuit CAH
    Mouthpiece, Breathing BYP

    Proprietary Names

    Spiro-SP TrueFlow Sensor EasyOne Sky Spirometer EasyOne Pro LAB Respiratory Analysis System EasyOne Pro/Pro LAB EasyOne Spirometer Easy on-PC Spirometer EasyOne Air Spirometer EasyOne Filter SP EasyOne Filter FT EasyOne Pro Respiratory Analysis System EasyOne FlowTube Filter Adapter SP Spirette Filter Adapter FT Spirette M Spirette FA Pro/LAB

    Establishment Types

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