BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Bur PM2-70 80K Diam EC 4.5 St

    Reg #: 3003800209 · FEI: 3003800209 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    187
    Establishment Types
    4
    Classifications
    3

    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
    K221184

    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
    Bur, Ear, Nose And Throat EQJ
    Microdebrider, Ent, High Speed, Single Use, Reprocessed NLY
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    Bur PM2-70 80K Diam EC 4.5 St Bur PM2-70 80K FC 6 St Bur PM2-125 80K Diam EC 3.8 St Bur PM2-125 80K Steel 6 St ShBlade Straight 3 mm SS St Bur OSSEOSTAP Carb 0.5 mm St Bur PM2-70 80K Diam 1 St Bur PM2-70 80K Carb 2.7 St Bur PM2-95 80K Steel 2.3 St Bur PM2-70 80k Steel 0.6 St Bur PM2-70 80K Diam 0.6 St Bur PM2-70 80K Carb 1.8 St Bur PM2-95 80K Diam C 4 St Bur PM2-95 80K Steel 1 St PM2-S70HD Bur PM2-70 80K Diam EC 6 St Bur PM2-70 80K FC 0.5 St Bur PM2-125 80K Diam EC 4.7 St ShBlade Straight 3.5 mm SS St Bur OSSEOSTAP Carb 0.6 mm St Irrigation line 5 m Bur PM2-70 80K Carb 0.5 St Bur PM2-125 80K Diam 2.3 St Bur PM2-150 80K Mstick 3 St ShBlade 40 Convx 3 mm DS St ShBlade Straight 4 mm DS RU St PM2-A70 Bur PM2-95 80K Diam 1.8 St ShBlade Straight 3.5 mm SM St Bur OSSEOSTAP Carb 1 mm St PM2-S70 Bur PM2-70 80k Steel 2.3 St Bur PM2-150 80k Diam 3.1 St ShBlade 60 Concv 3 mm DS St Bur OSSEOSTAP Diam 1.8 mm St PM2-A125 Bur PM2-70 80k Steel 6 St Bur PM2-95 80K Diam 4 St Bur PM2-95 80K Drum 4 x 8 St Bur OSSEOSTAP Carb 2.3 mm St 80K/RAPIDO Cable Bur PM2-70 80k Steel 1.8 St Bur PM2-125 80K Diam C 5 St Bur PM2-150 80k Diam 1.8 St ShBlade 40 Adeno 4 mm DS St Bur OSSEOSTAP Diam 1.4 mm St NANO Cable Bur PM2-70 80k Steel 1 St Bur PM2-70 80K Carb 1.4 St Bur PM2-125 80K Diam C 3.1 St Bur PM2-95 80K Diam C 6 St ShBlade 15 Concv 4 mm DS St ShBlade 120 Concv 4 mm DS St Bur OSSEOSTAP Diam 1 mm St Bur PM2-70 80K Diam C 2.3 St Bur PM2-70 80K FC 3 St Bur PM2-125 80K Steel 4 St ShBlade Straight 3 mm DS St Bur PM2-70 80K Diam 7 St Bur PM2-70 80K FC 2.3 St Bur PM2-125 80K Steel 3.1 St S120 Cable PM2-S125 Bur PM2-70 80K FC 5 St Bur PM2-125 80K Diam EC 6 St ShBlade Straight 4 mm SS St Bur OSSEOSTAP Carb 0.7 mm St Bur PM2-70 80k Steel 3.1 St Bur PM2-150 80k Diam C 3.1 St Bur PM2-125 80K Mstick 1.8 St ShBlade 60 Convx 4 mm DS St Perfo OSSEOSTAP 0.35 mm St PM2-A70HD Bur PM2-95 80K Diam 2.3 St ShBlade Straight 4 mm SM St Bur OSSEOSTAP Carb 1.4 mm St PM2-A95 Bur PM2-95 80K Diam 3.1 St Bur PM2-95 80K Mstick 3 St ShBlade 40 Concv 3 mm DS St Bur OSSEOSTAP Carb 1.8 mm St Bur PM2-70 80k Steel 4.5 St Bur PM2-70 80K Diam 4.5 St Bur PM2-70 80K FC 1 St Bur PM2-95 80K Mstick 1.8 St Bur PM2-125 80K Drum 5 x 10 St PM2-A150 Bur PM2-70 80k Steel 7 St Bur PM2-95 80K Diam C 3.1 St Bur PM2-95 80K Drum 5 x 10 St Bur OSSEOSTAP Diam 0.6 mm St Bur PM2-70 80k Steel 0.8 St Bur PM2-70 80K Diam 0.8 St Bur PM2-70 80K Carb 2.3 St Bur PM2-95 80K Steel 1.8 St Bur PM2-70 80k Steel 2.7 St Bur PM2-150 80k Diam 4 St ShBlade 60 Concv 4 mm DS St Bur OSSEOSTAP Diam 2.3 mm St NANO Micromotor Bur PM2-70 80K Carb 1 St Bur PM2-125 80K Diam 4 St Bur PM2-95 80K Diam C 5 St S120 Shaver ShBlade Laryn 3.5 x 270 mm SM St ShBlade 90 Concv 4 mm DS St Bur OSSEOSTAP Diam 0.8 mm St Bur PM2-70 80K Diam 1.8 St Bur PM2-70 80K Mstick 1.8 St Bur PM2-70 80K Carb 3.5 St Bur PM2-95 80K Steel 4 St Bur PM2-150 80K Steel 4 St PM2-S150 Bur PM2-70 80K FC 7 St Bur PM2-95 80K Diam 1 St ShBlade Straight 3 mm SM St Bur OSSEOSTAP Carb 0.8 mm St ORiGO Control Unit Bur PM2 80K Steel TD 1.1 x 5 St Bur PM2-70 80K Carb 6 St Bur PM2-125 80K Diam 1 St Bur PM2-95 80K Diam EC 4.7 St ShBlade Straight 3 mm DS RU St Bur PM2-70 80K Diam 2.3 St Bur PM2-70 80K Mstick 3 St Bur PM2-70 80K Carb 4 St Bur PM2-95 80K Steel 5 St Bur PM2-70 50K Carb Cone 6 St ShBur straight cyl 3.1 mm St ORiGO Foot Pedal Bur PM2 80K Router 12.8 mm St Bur PM2-70 80K Carb 7 St Bur PM2-125 80K Diam 1.8 St Bur PM2-150 80K Mstick 1.8 St ShBlade 40 Concv 4 mm DS St ShBlade Straight 3.5 mm DS RU St Bur PM2-70 80K Diam 1.4 St Bur PM2-70 80K Carb 3.1 St Bur PM2-95 80K Steel 3.1 St Bur PM2-150 80K Steel 3.1 St Bur PM2-70 80K Diam 2.7 St Bur PM2 80K SteelTD 1.5 x 12 St Bur PM2-70 80K Carb 4.5 St Bur PM2-70 80K FC 3.5 St Bur PM2-95 80K Steel 6 St Bur PM2-70 50K Carb Cone 7 St ShBur 15 DCR 3.1 mm St Bur PM2-70 80K Diam 3.1 St Bur PM2 80K Steel TD 1.1 x 4 St Bur PM2-70 80K Carb 5 St Bur PM2-70 80K FC 4.5 St Bur PM2-95 80K Diam EC 3.8 St ShBur 60 Cyl 3 mm St Bur PM2-70 80K Diam C 3.1 St Bur PM2-70 80K FC 4 St Bur PM2-125 80K Steel 5 St ShBlade Straight 3.5 mm DS St OSSEOSTAP Control Unit Bur PM2-70 80k Steel 3.5 St Bur PM2-70 80K Diam 3.5 St Bur PM2-150 80k Diam C 4 St Bur PM2-125 80K Mstick 3 St Bur PM2-70 80K Diam 6 St Bur PM2-70 80K FC 2 St Bur PM2-125 80K Steel 2.3 St RAPIDO Micromotor Bur PM2-70 80k Steel 1.4 St Bur PM2-125 80K Diam C 4 St Bur PM2-150 80k Diam 1 St ShBlade 15 Convx 4 mm DS St OSSEOSTAP + Cable Bur OSSEOSTAP Diam 1.2 mm St Irri clip ORIGO NANO/RAPIDO Bur PM2-70 80K Carb 0.8 St Bur PM2-125 80K Diam 3.1 St Bur PM2-95 80K Diam EC 6 St ShBlade Laryn 3.5 x 220 mm SM St ShBur15 DCR Diam 3 mm St Bur OSSEOSTAP Diam 0.7 mm St Bur PM2-70 80k Steel 4 St Bur PM2-70 80K Diam 4 St Bur PM2-150 80k Diam C 5 St Bur PM2-125 80K DrumC 4 x 8 St Bur PM2-70 80k Steel 5 St Bur PM2-70 80K Diam 5 St Bur PM2-70 80K FC 1.5 St Bur PM2-125 80K Steel 1.8 St

    Establishment Types

    Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device