Statistics for Bien-Air Dental SA

142Total Devices

12Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

5Countries

Certificate health for Bien-Air Dental SA

No certificates registered for this manufacturer.

Showing 26–50 of 142 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
1600873-001	`1600873-001`	`J00716008730011`	1	On the market
1601143-001	`1601143-001`	`J00716011430011`	1	On the market
1601144-001	`1601144-001`	`J00716011440011`	1	On the market
1601411-001	`1601411-001`	`J00716014110011`	1	On the market
1601137-001	`1601137-001`	`J00716011370011`	1	On the market
1601136-001	`1601136-001`	`J00716011360011`	1	On the market
1601139-001	`1601139-001`	`J00716011390011`	1	On the market
1601138-001	`1601138-001`	`J00716011380011`	1	On the market
1601235-001	`1601235-001`	`J00716012350011`	1	On the market
1601267-001	`1601267-001`	`J00716012670011`	1	On the market
1601236-001	`1601236-001`	`J00716012360011`	1	On the market
1601237-001	`1601237-001`	`J00716012370011`	1	On the market
1601246-001	`1601246-001`	`J00716012460011`	1	On the market
CABLE MX LED 3M	`1600881-001`	`J00716008810011`	1	On the market
CABLE MX-i LED	`1601069-001`	`J00716010690011`	1	On the market
1601161-001	`1601161-001`	`J00716011610011`	1	On the market
1601160-001	`1601160-001`	`J00716011600011`	1	On the market
CABLE MX-I LED 3RD GEN	`1601009-001`	`J00716010090011`	1	On the market
1601147-001	`1601147-001`	`J00716011470011`	1	On the market
1600995-001	`1600995-001`	`J00716009950011`	1	On the market
1600994-001	`1600994-001`	`J00716009940011`	1	On the market
1601275-001	`1601275-001`	`J00716012750011`	1	On the market
1600784-001	`1600784-001`	`J00716007840011`	1	On the market
1600883-001	`1600883-001`	`J00716008830011`	1	On the market
1601074-001	`1601074-001`	`J00716010740011`	1	On the market

Devices placed in 5 countries

EUDAMED update: Mar 13, 2025

CH-MF-000014661

Active

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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