Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003800209

FEI Number

3003800209

Entity Name

BIEN-AIR SURGERY SA

City/State/Country

Le Noirmont Jura, CH

Establishment Address

rue de l Ouest 2b, Le Noirmont Jura 2340, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Bien-Air Surgery SA (Owner Number: 10024150)

Owner / Operator Contact Address

rue de l'Ouest 2b, Le Noirmont, CH-JU 2340, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	Class 2	874.4250	2008-02-08
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-05-05
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2011-09-20
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2018-07-05
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2018-07-05
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2021-01-28
DWI	Saw, Electrically Powered	General, Plastic Surgery	Class 1	878.4820	2008-04-02
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2022-12-13
HBC	Motor, Drill, Electric	Neurology	Class 2	882.4360	2022-12-13
DWH	Blade, Saw, Surgical, Cardiovascular	General, Plastic Surgery	Class 1	878.4820	2012-12-20

Official Correspondent

Rivo RAZAFINTSEHENO

US Agent Details

ARTHUR MATEEN Business: BIEN AIR USA, INC. Email: arthur.mateen@bienair.com Phone: (949) 4776050

Related Public Records

Same Entity

Bien-Air Surgery SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964548	Linvatec Corp.	APEX UNIVERSAL DRIVE SYSTEM	1997-01-17
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003800209. Last updated year: 2026. Please use registration number 3003800209 when referencing this establishment in official correspondence.