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Bien Air Surgery INTRA Drill Handpieces - HSA Registration DE0510249

Access comprehensive regulatory information for Bien Air Surgery INTRA Drill Handpieces in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510249 and owned by Bien Air Surgery SA. The device was registered on January 16, 2025.

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
DE0510249
Bien Air Surgery INTRA Drill Handpieces
HSA Registration Number: DE0510249
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Product Description

INTRA handpieces are intended to transmit the rotational energy from the motor to the burs for cutting and shaping bones.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0510249
Registration Date
January 16, 2025
Change Notification Approval Date
April 22, 2025
Retention Due Date
January 15, 2026
Product Owner
Short Name
Bien Air Surgery SA
Address
Rue de l'Ouest 2b,, 2340 Le Noirmont, SWITZERLAND
Registrant
Address
8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Importer
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #03-02, SINGAPORE 149555 8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Model Information
Model Name(s)
INTRA Handpiece,70 mm,angled INTRA Handpiece,70 mm,straight INTRA Handpiece,125 mm,angled
Model Identifier(s)
262570 262571 262572