BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Polichem SA

    Reg #: 3005427465 · FEI: 3005427465 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

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    Registration Details

    Registration Name
    Polichem SA
    Registration Number
    3005427465
    FEI Number
    3005427465
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via Angelo Maspoli 11, Polichem SA, Via Angelo Maspoli 11, 6850 Mendrisio, Switzerland
    City
    Mendrisio Ticino
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K083087

    Owner / Operator

    Firm Name
    Polichem SA
    Operator Number
    10036234
    Address
    Via Angelo Maspoli 11
    City
    Mendrisio
    State
    Ticino
    Postal Code
    6850
    Country
    CH
    Correspondent
    Francesc Binefa

    US Agent

    Business Name
    Regulatory/Quality Management Information Source, Inc.
    Contact Name
    Barry Sands
    Address
    110 Haverhill Rd Ste 524
    City
    Amesbury
    State
    MA
    ZIP
    01913
    Country
    US
    Email
    [email protected]
    Phone
    978 8345701

    Products

    Device Name Product Code
    Bandage, Liquid KMF

    Proprietary Names

    Genadur

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility