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Bien-Air SA Switzerland

Switzerland · Bienne

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

17listed device types

Class I 14Class II 3Class III 0

plus 25 registration records and 9 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

32registered devices

Class II 32

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

7registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

11active device licences

Class II 11

44 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States25 registration records, 9 510(k), 0 PMA

Brazil32 confirmed, 0 excluded

Saudi Arabia7 confirmed, 0 excluded

Canada11 confirmed, 0 excluded

Manufacturer names merged into this page: BIEN-AIR DENTAL SA · BIEN-AIR SURGERY SA · Bien-Air Dental SA · Bien-Air Portugal Unipessoal LDA · Bien-Air Dental

Same-named companies — This database also contains companies with near-identical names: Bien-Air Dental, SA, Bien-Air Portugal Unipessoal LDA, BIEN-AIR SURGERY SA, Bien Air USA, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

11998

11999

12004

22009

12015

12018

22022

FDA listed device types

showing 8 of 17

Motor, Surgical Instrument, Ac-Powered 1Controller, Foot, Handpiece And Cord 1Handpiece, Air-Powered, Dental 1Bur, Surgical, General & Plastic Surgery 1Unit, Operative Dental 1Bur, Ear, Nose And Throat 1Microdebrider, Ent, High Speed, Single Use, Reprocessed 1Blade, Saw, Surgical, Cardiovascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K221184	ORiGO System	2022-11-02
US	K213697	ORiGO System	2022-10-31
US	K173066	OSSEODUO Shaver and Drill System	2018-06-22
BR	10099439029	Brocas de Perfuração Óssea Bien air diamantadas	Class II
BR	10099439032	Brocas de Perfuração Óssea Bien air - Aço Inoxidável	Class II
BR	81363889002	CÂNULAS PARA SHAVER CIRÚRGICO BIEN AIR, ESTÉREIS E DESCARTÁVEIS	Class II
SA	ME0000012077SFDAA00005	SPRAYNET®	—
SA	ME0000012077SFDAA00002	AQUACARE®	—
CA	70477	OPTIMA MX	Class II
CA	70483	BOARD (CONVERTORS AND ELECTRONIC BOARDS)	Class II
CA	71124	HANDPIECE CA/PM	Class II

Bien-Air SA Switzerland

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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