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BIEN-AIR SURGERY SA

Switzerland·CH-MF-000016376

Last updated September 17, 2026

Information

Country: Switzerland
Address: 2B, Rue de l'Ouest, Le Noirmont, Switzerland
Website: surgery.bienair.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Rivo Razafintseheno
EUDAMED SRN: CH-MF-000016376
FDA FEI Number: 3003800209
DUNS Number: —

Catalogue (47)

Device	Model / Reference	Registries	Class	Status
Connecting Cable INTRA	20261233	EUDAMED	Class I	Active
Bur PM2-MIS 150 steel 4.0 St	1100511	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS P160 Mstick 1.8St	1100684	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS P160 steel 4.0St	1100680	EUDAMEDFDA UDI	Class IIa	Active
BurPM2-MIS 150 diam 2.0 St	1100500	EUDAMEDFDA UDI	Class IIa	Active
NANO Cable	1600865-001	EUDAMEDFDA UDI	Class I	Active
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece	K143492	FDA 510(k)	Class II	Active
Osseoduo, Shaver Handpiece S80 And S120, Micromotor 80k	K083720	FDA 510(k)	Class II	Active
ORiGO System	K221184	FDA 510(k)	Class II	Active
ORiGO System	K213697	FDA 510(k)	Class II	Active
OSSEODUO Shaver and Drill System	K173066	FDA 510(k)	Class II	Active
Bur PM2-MIS P160 steel 3.0 St	1100679	EUDAMEDFDA UDI	Class IIa	Active
E-type Sterilization Tray	1600477	EUDAMED	Class I	Active
PM2-Nose MIS D150	1502375	EUDAMEDFDA UDI	Class IIa	Active
Pm2-S Mis	1601028	EUDAMEDFDA UDI	Class IIa	Active
BurPM2-MIS 150 steel 3.0 St	1100499	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS P160 diam 3.0 St	1100682	EUDAMEDFDA UDI	Class IIa	Active
PM2-Nose MIS P160	1502938	EUDAMEDFDA UDI	Class IIa	Active
ORIGO Foot Pedal	1601082	EUDAMEDFDA UDI	Class I	Active
Pm2-A Mis	1601027	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS P160 diam C 3.0St	1100687	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS D150 diam C 4.0St	1100677	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS P160 Mstick 3.0St	1100685	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS 150 Mstick 3.0 St	1100503	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2 MIS 150 steel 2.0 St	1100498	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS 150 diam C Ms 3 St	1100504	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS P160 steel 2.0 St	1100678	EUDAMEDFDA UDI	Class IIa	Active
NANO Cable 5m 10poles	1600927-001	EUDAMEDFDA UDI	Class I	Active
Bur PM2-MIS P160 diam C 4.0St	1100688	EUDAMEDFDA UDI	Class IIa	Active
ORIGO Control Unit	1601048	EUDAMEDFDA UDI	Class IIa	Active
BASCH Cable	1600342-001	EUDAMEDFDA UDI	Class I	Active
Bur PM2-MIS D150diam C 2.0 St	1100676	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS 150 diam 3.0 St	1100501	EUDAMEDFDA UDI	Class IIa	Active
80K / RAPIDO / PM PERFO Cable	1600519-001	EUDAMEDFDA UDI	Class I	Active
PM2 Sterilization Tray 300025	1600962	EUDAMED	Class I	Active
BurPM2-MIS 150 Mstick 1.8 St	1100502	EUDAMEDFDA UDI	Class IIa	Active
S120 Cable	1600629-001	EUDAMEDFDA UDI	Class I	Active
Bur PM2-MIS P160 diam 4.0 St	1100683	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2-MIS P160 diam C 2.0St	1100686	EUDAMEDFDA UDI	Class IIa	Active
OSSEOSTAP Sterilization Tray	1600669	EUDAMED	Class I	Active
S120 Sterilization Tray	1600828	EUDAMED	Class I	Active
PM2 Sterilization Tray Neuro	1600949	EUDAMED	Class I	Active
Bur PM2-MIS P160 diam 2.0 St	1100681	EUDAMEDFDA UDI	Class IIa	Active
Bur PM2 MIS 150 diam 4.0 St	1100512	EUDAMEDFDA UDI	Class IIa	Active
PM PERFO Cable 5m 10poles	1600930-001	EUDAMEDFDA UDI	Class I	Active
PM2 Sterilization Tray ENT	1600948	EUDAMED	Class I	Active
80K / RAPIDO Cable 5m 10poles	1600929-001	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

Bien-Air Europe Sàrl FR

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Bien-Air Surgery SA US