Bien-Air Dental SA
Schweizer Dentalhandstück und Mikromotor OEM für den Dentalgroßhandel.
Bien-Air Dental stellt in seinem Werk in Biel in der Schweiz Präzisionsturbinen, Winkelstücke, Handstücke und Mikromotoren her. Das 1959 gegründete Unternehmen verkauft an Dentalgerätehändler und Praxisgroßhändler in über 100 Ländern. Die Produkte sind CE-gekennzeichnet und nach ISO 13485 zertifiziert.
- Type
- brand seeking distribution
- Location
- Biel/Bienne, Switzerland
- Founded
- 1959
- Website
- bienair.com
- Categories
- Medizin- & Gesundheitsbedarf, Dentalbedarf & -geräte
- Markets
- Schweiz, Deutschland, Frankreich, Japan, Vereinigte Staaten
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)