BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    PMRM 1122 70mm

    Reg #: 3003800209 · FEI: 3003800209 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIEN-AIR SURGERY SA
    Registration Number
    3003800209
    FEI Number
    3003800209
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    rue de l Ouest 2b
    City
    Le Noirmont Jura
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K792159

    Owner / Operator

    Firm Name
    Bien-Air Surgery SA
    Operator Number
    10024150
    Address
    rue de l'Ouest 2b
    City
    Le Noirmont
    State
    Jura
    Postal Code
    2340
    Country
    CH
    Correspondent
    Rivo RAZAFINTSEHENO

    US Agent

    Business Name
    BIEN AIR USA, INC.
    Contact Name
    ARTHUR MATEEN
    Address
    5 CORPORATE PARK, SUITE 160
    City
    Irvine
    State
    CA
    ZIP
    92606
    Country
    US
    Email
    [email protected]
    Phone
    800 4332436

    Products

    Device Name Product Code
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    PMRM 1122 70mm PMAM 1122 125mm PMAM 1122 70mm BASCH-1 Micromotor BASCH Cable PMAM 1122 95mm PMAM 1221 70mm OSSEODOC Control Unit OSSEODOC Foot Pedal PM 1124 46mm BASCH Micromotor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device