Singapore HSA registration DE0510249
Bien Air Surgery INTRA Drill Handpieces
Singapore·CLASS B·Bien Air Surgery SA·Registered January 16, 2025Device 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 description
INTRA handpieces are intended to transmit the rotational energy from the motor to the burs for cutting and shaping bones.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B