Bien-Air Dental SA
Pieza de mano dental suiza y micromotor OEM para venta al por mayor de odontología.
Bien-Air Dental fabrica turbinas de precisión, contraángulos, piezas de mano rectas y micromotores en su fábrica de Biel, Suiza. Fundada en 1959, la empresa vende a distribuidores de equipos dentales y mayoristas de consultorios en más de 100 países. Sus productos cuentan con la marca CE y la certificación ISO 13485.
- Type
- brand seeking distribution
- Location
- Biel/Bienne, Switzerland
- Founded
- 1959
- Website
- bienair.com
- Categories
- Suministros médicos y sanitarios, Suministros y equipos dentales
- Markets
- Suiza, Alemania, Francia, Japón, Estados Unidos
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
- places-goods-on-market (green), checked 2026-08-21 Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
- registered-manufacturer (green), checked 2026-08-21 Swissmedic, swissdamed register of Swiss and Liechtenstein economic operators for medical devices
- registry-active-global (green), checked 2026-07-21 Zefix (Swiss commercial registry)
- sanctions-clear (green), checked 2026-07-21 OpenSanctions
- fda-registered (green), checked 2026-07-21 FDA
Claimed certifications
- ISO 9001, Quality Management IAF CertSearch
- ISO 13485, Medical Devices Quality IAF CertSearch
- CE Marking EU NANDO (notified bodies)
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)