EUDAMED update: Mar 13, 2025

Bien-Air Dental SA

CH-MF-000014661

Active142 devices

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

Bien-Air Dental SA is a medical device manufacturer registered in EUDAMED. The company has 142 devices on the EU market across 32 countries. Headquartered in Biel/Bienne, Switzerland. Explore the regulatory profile, devices and certificates on MD Atlas.

About Bien-Air Dental SA

: 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

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

Competent authority

Name: Agence Nationale de Sécurité du Médicament et des Produits de Santé

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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Connected operators

Importers

8 EU importers place this manufacturer's devices

Data export

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
PM 1:2	PM 1:2	`1600436-001`	`J00716004360011`	1	On the market
Air motor AQUILON 830 SR	Air motor AQUILON 830 SR	`1600362-001`	`J00716003620011`	1	On the market
BOARD DMCX	BOARD DMCX	`1600811-001`	`J00716008110011`	1	On the market
BOARD DMX3 CAN BOX	BOARD DMX3 CAN BOX	`1600982-005`	`J00716009820051`	5	On the market
BOARD DMX3 FULL OPEN	BOARD DMX3 FULL OPEN	`1600903-00A`	`J007160090300A1`	1	On the market
BOARD DMX3 M Bornier	BOARD DMX3 M Bornier	`1502122-001`	`J00715021220011`	1	On the market
BOARD DMX3 M Bornier	BOARD DMX3 M Bornier	`1502122-010`	`J00715021220101`	10	On the market
BOARD DMX3 M BtoB	BOARD DMX3 M BtoB	`1502123-010`	`J00715021230101`	10	On the market
BOARD DMX3 M BtoB	BOARD DMX3 M BtoB	`1502123-001`	`J00715021230011`	1	On the market
BOARD DMX3 M BtoW	BOARD DMX3 M BtoW	`1502121-010`	`J00715021210101`	1	On the market
BOARD DMX3 MCX 100 RPM	BOARD DMX3 MCX 100 RPM	`1600903-00B`	`J007160090300B1`	1	On the market
CA 1:1	CA 1:1	`1600424-001`	`J00716004240011`	1	On the market
CA 1:1 L	CA 1:1 L	`1600384-001`	`J00716003840011`	1	On the market
CA 1:1 L Micro-Series	CA 1:1 L Micro-Series	`1600691-001`	`J00716006910011`	1	On the market
CA 1:2.5 L	CA 1:2.5 L	`1601163-001`	`J00716011630011`	1	On the market
CA 1:2.5 L MS	CA 1:2.5 L MS	`1601164-001`	`J00716011640011`	1	On the market
CA 1:5	CA 1:5	`1600325-001`	`J00716003250011`	1	On the market
CA 1:5 L	CA 1:5 L	`1600386-001`	`J00716003860011`	1	On the market
CA 1:5 L Micro-Series	CA 1:5 L Micro-Series	`1600690-001`	`J00716006900011`	1	On the market
CA 20:1	CA 20:1	`1600632-001`	`J00716006320011`	1	On the market
CA 20:1 L	CA 20:1 L	`1600598-001`	`J00716005980011`	1	On the market
CA 20:1 L KM	CA 20:1 L KM	`1600785-001`	`J00716007850011`	1	On the market
CA 20:1 L KM Micro-Series	CA 20:1 L KM Micro-Series	`1600786-001`	`J00716007860011`	1	On the market
CA 20:1 L Micro-Series	CA 20:1 L Micro-Series	`600692-001`	`J00716006920011`	1	On the market
CA 20:1 LKM Micro-Series	CA 20:1 LKM Micro-Series	`1600874-001`	`J00716008740011`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
PM 1:2	PM 1:2	`1600436-001`	`J00716004360011`	1	On the market
Air motor AQUILON 830 SR	Air motor AQUILON 830 SR	`1600362-001`	`J00716003620011`	1	On the market
BOARD DMCX	BOARD DMCX	`1600811-001`	`J00716008110011`	1	On the market
BOARD DMX3 CAN BOX	BOARD DMX3 CAN BOX	`1600982-005`	`J00716009820051`	5	On the market
BOARD DMX3 FULL OPEN	BOARD DMX3 FULL OPEN	`1600903-00A`	`J007160090300A1`	1	On the market
BOARD DMX3 M Bornier	BOARD DMX3 M Bornier	`1502122-001`	`J00715021220011`	1	On the market
BOARD DMX3 M Bornier	BOARD DMX3 M Bornier	`1502122-010`	`J00715021220101`	10	On the market
BOARD DMX3 M BtoB	BOARD DMX3 M BtoB	`1502123-010`	`J00715021230101`	10	On the market
BOARD DMX3 M BtoB	BOARD DMX3 M BtoB	`1502123-001`	`J00715021230011`	1	On the market
BOARD DMX3 M BtoW	BOARD DMX3 M BtoW	`1502121-010`	`J00715021210101`	1	On the market
BOARD DMX3 MCX 100 RPM	BOARD DMX3 MCX 100 RPM	`1600903-00B`	`J007160090300B1`	1	On the market
CA 1:1	CA 1:1	`1600424-001`	`J00716004240011`	1	On the market
CA 1:1 L	CA 1:1 L	`1600384-001`	`J00716003840011`	1	On the market
CA 1:1 L Micro-Series	CA 1:1 L Micro-Series	`1600691-001`	`J00716006910011`	1	On the market
CA 1:2.5 L	CA 1:2.5 L	`1601163-001`	`J00716011630011`	1	On the market
CA 1:2.5 L MS	CA 1:2.5 L MS	`1601164-001`	`J00716011640011`	1	On the market
CA 1:5	CA 1:5	`1600325-001`	`J00716003250011`	1	On the market
CA 1:5 L	CA 1:5 L	`1600386-001`	`J00716003860011`	1	On the market
CA 1:5 L Micro-Series	CA 1:5 L Micro-Series	`1600690-001`	`J00716006900011`	1	On the market
CA 20:1	CA 20:1	`1600632-001`	`J00716006320011`	1	On the market
CA 20:1 L	CA 20:1 L	`1600598-001`	`J00716005980011`	1	On the market
CA 20:1 L KM	CA 20:1 L KM	`1600785-001`	`J00716007850011`	1	On the market
CA 20:1 L KM Micro-Series	CA 20:1 L KM Micro-Series	`1600786-001`	`J00716007860011`	1	On the market
CA 20:1 L Micro-Series	CA 20:1 L Micro-Series	`600692-001`	`J00716006920011`	1	On the market
CA 20:1 LKM Micro-Series	CA 20:1 LKM Micro-Series	`1600874-001`	`J00716008740011`	1	On the market

Bien-Air Dental SA

About Bien-Air Dental SA

Contact details for Bien-Air Dental SA

Competent authority

Officers and regulatory representatives of Bien-Air Dental SA

Connected operators

Importers

Export the 142 devices of Bien-Air Dental SA

Related searches

About Bien-Air Dental SA

Contact details for Bien-Air Dental SA

Competent authority

Officers and regulatory representatives of Bien-Air Dental SA

Statistics for Bien-Air Dental SA

Certificate health for Bien-Air Dental SA

Related documents

Devices by risk class

Device catalog for Bien-Air Dental SA

Device families (Basic UDI-DI) of Bien-Air Dental SA

Market presence of Bien-Air Dental SA

Connected operators

Importers

Export the 142 devices of Bien-Air Dental SA

Related searches

Certificate health for Bien-Air Dental SA

Statistics for Bien-Air Dental SA

Market presence of Bien-Air Dental SA

Devices by risk class

Device families (Basic UDI-DI) of Bien-Air Dental SA

Related documents

Device catalog for Bien-Air Dental SA