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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Bien-Air Dental SA — Manufacturer in Switzerland

EUDAMED update: Mar 13, 2025

Bien-Air Dental SA

CH-MF-000014661

Active

Address: Länggasse, 60 2504 Biel/Bienne
Role: Manufacturer
Date of registration: Oct 20, 2021
Country: CH Switzerland

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About Bien-Air Dental SA

SRN: CH-MF-000014661
Role: Manufacturer
Country: Switzerland
Organization name: Bien-Air Dental SA
EU VAT number: CHE-105.855.630
Trade register: CH-073.3.000.249-7
Date of registration: Oct 20, 2021

Contact details for Bien-Air Dental SA

Address: 60, LÄNGGASSE 2504 BIEL/BIENNE SWITZERLAND
Email: regulatory@bienair.com
Website: www.dental.bienair.com

Validator

Name: Agence Nationale de Sécurité du Médicament et des Produits de Santé
SRN: FR-CA-008
Phone: + 33 (1) 5587 3000
Email: contact.eudamed@ansm.sante.fr

Officers and regulatory representatives of Bien-Air Dental SA

BÉRIET Carine
• Conformity of the Technical Documentation and EU Declaration of conformity • Compliance with Post-Market Surveillance (PMS) following Article 10(10) • Compliance with the Vigilance Reporting obligations (Article 87 to 91) Art. 87- Reporting of serious incidents and field safety corrective actions Art. 90- Analysis of vigilance data Art. 91- Implementing acts • For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)
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Market presence of Bien-Air Dental SA

Devices placed in 5 countries

Austria99
France36
Finland4
Germany2
Belgium1

Devices by risk class

Certificate health for Bien-Air Dental SA

No certificates registered for this manufacturer.

Statistics for Bien-Air Dental SA

142Total Devices

12Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

5Countries

Device catalog for Bien-Air Dental SA

No devices registered for this manufacturer.