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Bien Air MEG-ENGINE II - HSA Registration DE0510007

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.

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CLASS B
DE0510007
Bien Air MEG-ENGINE II
HSA Registration Number: DE0510007
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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.

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 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