Bien-Air Dental SA
CH-MF-000014661 · Switzerland · Biel/Bienne
Bien-Air Dental SA is registered in the European database on medical devices as a manufacturer, with 142 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 142 |
|---|
Most frequent device types declared: 1600362-001, 1700493-001, CA&HP, CHIROPRO, Electric Micromtors.
Among these devices, 135 are declared active.
Authorised representative in the Union: Bien-Air Europe Sàrl.
Devices declared under this manufacturer
- BOARD DMCX
- BOARD DMX3 FULL OPEN
- CA 1:1 L Micro-Series
- Console iOptima INT 2xMX2
- HOSE 4VLM GREY
- HOSE ISOLITE/MC2 COILED BLACK
- HOSE ISOLITE/MC2 GREY
- HOSE LIGHT MOTOR
- HOSE MCX GREY 2.2m
- HOSE MCX Grey 400° Ø20.2x40
- MAINT LUBRIFLUID (BOX 6 CANS)
- Mot MC3 IR
Showing 12 of 142 declared devices.
Catalogue references include 1600064-006, 1600120-001, 1600315-001, 1600811-001, 1600903-00A, 1600920-001.
European nomenclature codes declared: Z12110199, Z12110101, V0799.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIEN-AIR DENTAL SA (CH) · FDA 9614446 |
| Devices in EUDAMED | 142 |
| Country of registration | Switzerland |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIEN-AIR DENTAL SA |
What it holds in Canada
| Licences on record | 29 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 29 |
| First licensed | 2006-02-15 |
Licence types: Device Family (9), Device Group Family (8), System (6), Single Device (4).
Licensed under: DENTAL MOTORS, HOSES AND CABLES FOR DENTAL DEVICES, HANDPIECE DENTAL, COUPLING ADAPTER FOR DENTAL MOTORS, TURBINE MOTORS, HANDPIECE DENTAL.
North American profile: Both markets. Bien-Air Dental SA is registered in both the United States and Canada.