BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BIEN-AIR SURGERY SA

    Reg #: 3003800209 · FEI: 3003800209 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    456
    Establishment Types
    6
    Classifications
    11

    Registration Details

    Registration Name
    BIEN-AIR SURGERY SA
    Registration Number
    3003800209
    FEI Number
    3003800209
    Status
    Active
    Expiry Year
    2026
    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
    949 4776050

    Products

    Device Name Product Code
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Tray, Surgical, Ent MMO
    Catheter, Irrigation GBX
    Motor, Drill, Electric HBC
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Saw, Electrically Powered DWI
    Blade, Saw, Surgical, Cardiovascular DWH
    Bur, Surgical, General & Plastic Surgery GFF
    Bur, Ear, Nose And Throat EQJ
    Microdebrider, Ent, High Speed, Single Use, Reprocessed NLY

    Proprietary Names

    BASCH Micromotor PMAM 1122 125mm PMAM 1122 95mm BASCH Cable PMAM 1221 70mm PMAM 1122 70mm OSSEODOC Control Unit BASCH-1 Micromotor PMRM 1122 70mm PM 1124 46mm OSSEODOC Foot Pedal Bur Holder Sterilization Tray PM2 Neuro Sterilization Tray PM2 ENT Sterilization Tray Sterilization Tray OSSEOSTAP Sterilization Tray S80/S120 Irri clip S120/80K/NANO/RAPIDO Tubing set for peristatic pump Bur PM2-70 80K Diam 2.3 St Bur PM2 80K Steel TD 1.1 x 5 St Bur PM2-95 80K Diam EC 3.8 St Bur Cranial Spiral 10mm St Bur PM2-125 80K Diam 1.8 St Bur PM2-125 80K Steel 1.8 St Bur PM2-70 80k Steel 3.1 St Bur PM2-150 80k Diam C 5 St Bur PM2-70 80K Diam EC 4.5 St Bur PM2-95 80K Steel 4 St Bur PM2-70 80k Steel 4.5 St Bur PM2-70 80K Diam 4.5 St Bur PM2-150 80K Mstick 1.8 St Bur PM2-70 80K Diam 7 St Bur PM2-95 80K Steel 1.8 St Bur PM2 80K SteelTD 1.5 x 12 St Bur PM2-95 80K Mstick 3 St Bur PM2-125 80K Diam 4 St Bur PM2-70 80k Steel 6 St Bur PM2-70 80K Diam 6 St Bur PM2-95 80K Steel 1 St Bur PM2-95 80K Diam1.8 St Bur PM2-125 80K Diam C 4 St Bur Cranial Spiral 15mm St Bur PM2-70 80k Steel 7 St Bur PM2-125 80K Steel 5 St OSSEODUO Foot Pedal Bur Cranial Straight 10mm St Bur PM2-125 80K Diam 1 St Bur PM2-125 80K Drum 5 x 10 St Bur PM2-70 80K Diam C 3.1 St Bur PM2-95 80K Steel 3.1 St Bur Cranial Straight 25 mm St Bur PM2-125 80K Steel 3.1 St Bur PM2-70 80k Steel 4 St Bur PM2-70 80K Diam 4 St Bur PM2-150 80K Steel 4 St Bur PM2-70 80k Steel 0.8 St Bur PM2-70 80K Diam 0.8 St Bur PM2-95 80K Diam C 3.1 St Bur PM2-150 80k Diam 1 St Bur PM2-70 80k Steel 0.6 St Bur PM2-70 80K Diam 0.6 St Bur PM2-125 80K Steel 6 St Bur PM2-70 80K Diam 2.7 St Bur PM2 80K Router 12.8 mm St Bur PM2-95 80K Diam EC 4.7 St Bur PM2-70 80K Diam 3.1 St Bur PM2-70 80K Mstick 1.8 St Bur PM2-95 80K Diam EC 6 St Bur PM2-125 80K Diam 2.3 St Bur PM2-70 80k Steel 1 St Bur PM2-70 80K Diam 1 St Bur PM2-95 80K Diam C 4 St Bur PM2-70 80K Diam 3.5 St Bur PM2-70 80K Mstick 3 St Bur PM2-95 80K Mstick 1.8 St Bur PM2-125 80K Diam 3.1 St Bur PM2-70 80K Diam C 2.3 St Bur PM2-95 80K Steel 2.3 St Bur PM2-70 80k Steel 5 St Bur PM2-70 80K Diam 5 St Bur PM2-95 80K Drum 5 x 10 St Bur PM2-150 80K Mstick 3 St Bur PM2-95 80K Diam2.3 St Bur PM2-125 80K Diam C 5 St Bur PM2-70 80k Steel 3.5 St Bur PM2-150 80K Steel 3.1 St Bur PM2-70 80K Diam 1.4 St Bur PM2-95 80K Diam C 5 St Bur PM2-70 80K Diam 1.8 St Bur PM2-95 80K Diam C 6 St Bur Cranial Straight 15mm St Bur PM2-125 80K Steel 4 St OSSEODUO Control Unit LUBRIFLUID Bur PM2-70 80k Steel 2.7 St Bur PM2-150 80k Diam C 4 St Bur PM2-70 80k Steel 1.8 St Bur PM2-125 80K Diam EC 6 St Bur PM2-150 80k Diam 4 St Bur Cranial Spiral 25mm St Bur PM2-125 80K Steel 2.3 St Bur PM2-95 80K Diam3.1 St Bur PM2-125 80K Diam EC 3.8 St Bur PM2-150 80k Diam 1.8 St Bur PM2-70 80k Steel 1.4 St Bur PM2-95 80K Diam4 St Bur PM2-125 80K Diam EC 4.7 St Bur PM2-150 80k Diam 3.1 St AQUACARE Bur PM2 80K Steel TD 1.1 x 4 St Bur PM2-95 80K Steel 6 St Bur PM2-125 80K DrumC 4 x 8 St Bur PM2-95 80K Diam1 St Bur PM2-95 80K Drum C 4 x 8 St Bur PM2-125 80K Diam C 3.1 St Bur PM2-70 80k Steel 2.3 St Bur PM2-125 80K Mstick 1.8 St Bur PM2-150 80k Diam C 3.1 St Bur PM2-70 80K Diam EC 6 St Bur PM2-95 80K Steel 5 St Bur PM2-125 80K Mstick 3 St Short Microsaw Blade 27x0.6mm Short Microsaw Blade 27x0.4mm Short Microsaw Blade 32x0.6mm Short Microsaw Blade 32x0.4mm Long Microsaw Blade 22x0.4mm Short Bullnose Blade 32x0.4mm Short Bullnose Blade 27x0.4mm Short Microsaw Blade 22x0.4mm Long Bullnose Blade 22x0.6mm Short Bullnose Blade 32x0.6mm Short Microsaw Blade 22x0.6mm Long Bullnose Blade 32x0.6mm Long Microsaw Blade 22x0.6mm Long Bullnose Blade 27x0.6mm Long Microsaw Blade 27x0.6mm Long Bullnose Blade 32x0.4mm Long Microsaw Blade 27x0.4mm Long Microsaw Blade 32x0.6mm Long Microsaw Blade 32x0.4mm Short Bullnose Blade 27x0.6mm Long Bullnose Blade 22x0.4mm Short Bullnose Blade 22x0.4mm Short Bullnose Blade 22x0.6mm Long Bullnose Blade 27x0.4mm Compass Micro Saw Sagittal Micro Saw Osseoscalpel Micro Saw Oscillating Micro Saw PM2-S70 Bur PM2-70 80K Carb 0.5 St Bur PM2-70 80K FC 1.5 St PM2-S125 Bur PM2-70 80K Carb 5 St PM2-A70HD PM2-A150 Bur PM2-70 80K Carb 3.5 St Bur PM2-70 80K Carb 1.8 St Bur PM2-70 80K FC 3 St PM2-A125 Bur PM2-70 80K Carb 3.1 St Bur PM2-70 80K Carb 2.7 St Bur PM2-70 80K FC 6 St NANO Micromotor Bur PM2-70 80K FC 1 St Cranio Guard 15mm rotating Bur PM2-70 80K Carb 4.5 St ORiGO Foot Pedal PM2-A70 RAPIDO Micromotor NANO Cable Bur PM2-70 80K Carb 0.8 St Bur PM2-70 80K Carb 1 St 80K/RAPIDO Cable Cranio Guard 10mm fix Bur PM2-70 80K Carb 1.4 St Bur PM2-70 80K FC 2.3 St Cranio Guard 10mm rotating Bur PM2-70 80K Carb 4 St PM2-A95 Bur PM2-70 80K FC 0.5 St PM2-S150 PM PERFO Cranio Guard 15mm fix PM PERFO Cable Cranio Guard 25mm fix Irrigation line 5 m PM2-S70HD Bur PM2-70 80K FC 3.5 St ORiGO Control Unit Bur PM2-70 80K FC 2 St Bur PM2-70 80K FC 5 St Bur PM2-70 80K FC 7 St Bur PM2-70 80K Carb 7 St Bur PM2-70 80K Carb 2.3 St Bur PM2-70 80K FC 4 St Bur PM2-70 80K FC 4.5 St Bur PM2-70 80K Carb 6 St 80K / RAPIDO / PM PERFO Cable OSSEOUNO Control Unit Nano Cable 80k Micromotor Zekrya Lindemann Round Bur Carbide 3.5x70mm Round Bur Steel 3.1x70mm St Round Bur Carbide 2.3x70mm Round Bur Diamond 3.1x70mm St Round Bur Diamond 4.5x70mm Round Bur Steel 0.6x70mm St Bur PM2-70 50K Steel 7 St Round Bur Carbide 1.4x70mm St Bur PM2-70 50K Diam 0.6x80 Round Bur Carbide 5x70mm Bur PM2-70 50K Carb Xcut 4 Bur PM2-70 50K Diam C 4 Bur PM2-70 50K Steel 2.7 St Round Bur Steel 4x70mm Bur PM2-70 50K Steel 4.5 Bur PM2-70 50K Diam 1 Round Bur Steel 1.8x70mm St Round Bur Carbide Crosscut 3.1 x70mm Bur PM2-70 50K Carb Conical 7 Round Bur Steel 2.3x70mm St Bur PM2-70 50K Carb 5 Bur PM2-70 50K Diam C 4.5 Round Bur Diamond 1x70mm St Round Bur Diamond C 6x70mm Round Bur Steel 7x70mm Bur PM2-70 50K Steel 1.8 Bur PM2-70 50K Carb 1.4 Bur PM2-70 50K Steel 6 St Bur PM2-70 50K Steel 7 Round Bur Diamond 7x70mm St Bur PM2-70 50K Diam 4.5 Round Bur Diamond 6x70mm St Bur PM2-70 50K Diam 2.7 Round Bur Diamond 0.6x70mm Round Bur Carbide Crosscut 6x70mm Round Bur Diamond C 5x70mm Bur PM2-70 50K Diam 3.5 Bur PM2-70 50K Steel 4.5 St Bur PM2-70 50K Carb 1.8 Bur PM2-70 50K Steel 0.6 St Bur PM2-70 50K Steel 5 Bur PM2-70 50K Carb 0.8 Bur PM2-70 50K Diam 1.8x80 Round Bur Diamond 2.7x70mm Bur PM2-70 50K Diam 4 Round Bur Carbide 1x70mm Bur PM2-70 50K Carb 2.3 Round Bur Carbide 5x70mm St Bur PM2-70 50K Diam 7 Round Bur Diamond 1.8x70mm Round Bur Carbide 0.5x70mm Round Bur Steel 1.4x70mm Round Bur Diamond C 7x70mm Round Bur Steel 2.7x70mm Bur PM2-70 50K Steel 2.3 Round Bur Steel 2.7x70mm St Round Bur Steel 3.5x70mm St Bur PM2-70 50K Carb Conical 6 Bur PM2-70 50K Steel 6 Round Bur Carbide 2.7x70mm St Bur PM2-70 50K Steel 3.1 Bur PM2-70 50K Diam 1.4 Round Bur Carbide 6x70mm Round Bur Diamond 2.3x70mm Round Bur Steel 0.8x70mm Round Bur Carbide 0.5x70mm St Round Bur Diamond 7x70mm Round Bur Carbide Crosscut 5x70mm Round Bur Steel 1.8x70mm Round Bur Steel 7x70mm St Bur PM2-70 50K Carb 7 Bur PM2-70 50K Steel 0.8 Bur PM2-70 50K Steel 1 Round Bur Steel 4.5x70mm St Bur PM2-70 50K Carb 4 Bur PM2-70 50K Diam 5 Bur PM2-70 50K Diam C 2.3 Bur PM2-70 50K Carb Xcut 6 Round Bur Diamond 0.6x70mm St Round Bur Diamond 5x70mm Round Bur Carbide 0.8x70mm St Bur PM2-70 50K Carb 4.5 Round Bur Carbide 3.5x70mm St Bur PM2-70 50K Diam 1x80 Round Bur Steel 6x70mm Round Bur Carbide 4.5x70mm Round Bur Carbide 3.1x70mm Round Bur Diamond 2.7x70mm St Round Bur Diamond C 3.1x70mm Bur PM2-70 50K Diam C 3.1 Round Bur Steel 01 x70mm Round Bur Carbide 3.1x70mm St Bur PM2-70 50K Diam C 3.5 Round Bur Diamond 3.5x70mm Round Bur Diamond 4x70mm Round Bur Diamond C 2.7x70mm Bur PM2-70 50K Diam 6 Round Bur Steel 6x70mm St Round Bur Diamond 1.8x70mm St Round Bur Diamond 6x70mm Round Bur Carbide 0.8x70mm Round Bur Steel 4x70mm St Bur PM2-70 50K Diam C 2.7 Bur PM2-70 50K Diam 0.8x80 Bur PM2-70 50K Diam C 6 Round Bur Carbide 1.8x70mm St Round Bur Carbide 2.3x70mm St Round Bur Steel 2.3x70mm Round Bur Diamond C 4x70mm Bur PM2-70 50K Carb Xcut 2.3 Bur PM2-70 50K Carb 3.5 Bur PM2-70 50K Carb Xcut 1.4 Bur PM2-70 50K Steel 1 St Round Bur Steel 1x70mm St Round Bur Steel 3.5x70mm Bur PM2-70 50K Steel 0.8 St Bur PM2-70 50K Steel 4 St Round Bur Diamond 1.4x70mm Bur PM2-70 50K Diam 0.6 Bur PM2-70 50K Diam 0.8 Round Bur Carbide 7x70mm St Round Bur Steel 5x70mm Round Bur Carbide 4.5x70mm St Round Bur Diamond C 2.3x70mm Round Bur Carbide 2.7x70mm Round Bur Carbide 1x70mm St Bur PM2-70 50K Steel 4 Bur PM2-70 50K Steel 1.8 St Bur PM2-70 50K Diam 1.8 Round Bur Diamond 3.5x70mm St Bur PM2-70 50K Carb 1 Bur PM2-70 50K Steel 2.7 Bur PM2-70 50K Steel 3.1 St Bur PM2-70 50K Steel 1.4 St Round Bur Diamond 4.5x70mm St Round Bur Carbide 1.8x70mm Round Bur Carbide Crosscut 4x70mm Bur PM2-70 50K Carb 0.5 Bur PM2-70 50K Steel 5 St Bur PM2-70 50K Steel 3.5 Round Bur Carbide 4x70mm St Bur PM2-70 50K Diam 1.4x80 Round Bur Carbide 1.4x70mm Bur PM2-70 50K Diam C 5 Round Bur Steel 0.8x70mm St Round Bur Steel 4.Sx70mm Bur PM2-70 50K Carb Xcut 5 Round Bur Diamond 0.8x70mm St Round Bur Diamond 5x70mm St Bur PM2-70 50K Carb 6 Round Bur Steel 3.1x70mm Round Bur Carbide 4x70mm Bur PM2-70 50K Steel 0.6 Round Bur Diamond 0.8x70mm Bur PM2-70 50K Steel 3.5 St Bur PM2-70 50K Steel 2.3 St Round Bur Carbide 6x70mm St Bur PM2-70 50K Carb Xcut 3.1 Bur PM2-70 50K Diam 3.1 Round Bur Carbide Crosscut 1.4x70mm Round Bur Diamond C 3.5x70mm Round Bur Steel 0.6x70mm Round Bur Diamond 1x70mm Bur PM2-70 50K Diam C 7 Round Bur Carbide Crosscut 2.3x70mm Round Bur Steel 5x70mm St Bur PM2-70 50K Carb 2.7 Round Bur Diamond 2.3x70mm St Round Bur Diamond 3.1x70mm Round Bur Diamond 1.4x70mm St Round Bur Diamond C 4.Sx70mm Bur PM2-70 50K Diam 2.3 Round Bur Steel 1.4x70mm St Round Bur Diamond 4x70mm St Bur PM2-70 50K Diam 2.3x80 Bur PM2-70 50K Carb 3.1 Round Bur Carbide 7x70mm Bur PM2-70 50K Steel 1.4 Bur PM2-70 50K Carb Cone 6 St ShBlade Straight 3 mm SM St Bur OSSEOSTAP Carb 0.8 mm St ShBur 15 DCR 3.1 mm St Bur PM2-70 80K Diam 3.1 St ShBlade Straight 3 mm SS St ShBlade 60 Concv 3 mm DS St Bur OSSEOSTAP Carb 0.5 mm St Bur OSSEOSTAP Diam 1.8 mm St S120 Cable ShBlade 15 Concv 4 mm DS St ShBlade 120 Concv 4 mm DS St Bur PM2-70 80K Diam 4.5 St ShBlade Straight 4 mm DS RU St Bur PM2-95 80K Diam 4 St ShBlade 40 Concv 4 mm DS St Bur OSSEOSTAP Carb 2.3 mm St S120 Shaver ShBlade 90 Concv 4 mm DS St ShBlade Laryn 3.5 x 220 mm SM St Bur OSSEOSTAP Diam 0.7 mm St Bur PM2-70 80K Diam 7 St Bur PM2-95 80K Diam 1 St ShBur straight cyl 3.1 mm St ShBlade Straight 3.5 mm DS St ShBlade 40 Adeno 4 mm DS St OSSEOSTAP Control Unit Bur OSSEOSTAP Diam 1.4 mm St ShBlade Straight 3 mm DS RU St Bur PM2-70 80K Diam 4 St ShBlade Straight 3.5 mm DS RU St Bur PM2-70 80K Diam 0.8 St Bur PM2-70 80K Diam 0.6 St Bur PM2-70 80K Diam C 2.3 St Bur PM2-95 80K Diam 1.8 St Bur PM2-70 50K Carb Cone 7 St ShBlade Straight 3.5 mm SM St Bur OSSEOSTAP Carb 1 mm St Bur PM2-95 80K Diam 2.3 St ShBlade Straight 4 mm SM St Bur OSSEOSTAP Carb 1.4 mm St Bur PM2-95 80K Diam 3.1 St ShBlade 40 Concv 3 mm DS St Bur OSSEOSTAP Carb 1.8 mm St ShBlade Straight 3 mm DS St ShBlade 15 Convx 4 mm DS St OSSEOSTAP + Cable Irri clip ORIGO NANO/RAPIDO Bur PM2-70 80K Diam 5 St ShBur15 DCR Diam 3 mm St ShBlade Laryn 3.5 x 270 mm SM St Bur OSSEOSTAP Diam 0.8 mm St Bur PM2-70 80K Diam 3.5 St ShBlade Straight 3.5 mm SS St ShBlade Straight 4 mm SS St Bur PM2-70 80K Diam 6 St Bur PM2-95 80K Drum 4 x 8 St Bur PM2-70 80K Diam 2.7 St Bur PM2-70 80K Diam 1.8 St ShBur 60 Cyl 3 mm St Bur PM2-70 80K Diam 1 St Bur OSSEOSTAP Diam 1 mm St Bur PM2-70 80K Diam 1.4 St Bur OSSEOSTAP Diam 1.2 mm St ShBlade 60 Convx 4 mm DS St Bur OSSEOSTAP Carb 0.7 mm St Perfo OSSEOSTAP 0.35 mm St ShBlade 40 Convx 3 mm DS St Bur OSSEOSTAP Diam 0.6 mm St Bur PM2-70 80K Diam 2.3 St ShBlade 60 Concv 4 mm DS St Bur OSSEOSTAP Carb 0.6 mm St Bur OSSEOSTAP Diam 2.3 mm St

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Manufacture Medical Device for Another Party (Contract Manufacturer)