Singapore HSA registration DE0510007
Bien Air MEG-ENGINE II
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0510007
- Registration Date
- November 05, 2024
- Retention Due Date
- November 04, 2025
Product description
All MEG- ENGINE II devices are intended to be used in dental implantology. The consoles are designed to operate a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants.
Product Owner
- Short Name
- Bien-Air Dental SA
- Address
- Lànggasse 60, 2504 Biel/Bienne, SWITZERLAND
Registrant
- Address
- 10 UBI CRESCENT, UBI TECHPARK, #04-66, SINGAPORE 408564
Importer
- Address
- 13 UBI CRESCENT, #03-00, SINGAPORE 408574
Model information
- Model Name(s)
- Handpiece Holder Bracket Cable fixing hook Foot Controlor Contra Angle Hanpiece Micro Motor Motor Cable Meg-Engine II
- Model Identifier(s)
- 1301575 1303393 1307727 1600631-001 1600692-001 1601008-001 1601009-001 1601100-001
About this record
Access comprehensive regulatory information for Bien Air MEG-ENGINE II in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510007 and owned by Bien-Air Dental SA. The device was registered on November 05, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B