Singapore HSA registration DE0510248
Bien Air Surgery High-Speed 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
- DE0510248
- Registration Date
- January 16, 2025
- Change Notification Approval Date
- April 22, 2025
- Retention Due Date
- January 15, 2026
Product description
High speed handpieces are intended to transmit the rotational energy from the motor to the burs without modifying the energy for cutting and shaping bones including the spine and cranium.
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)
- HS-Handpiece,straight,70mm,80k HS-Handpiece,angled,70mm,80k HS-Handpiece,angled,70mm,80k HS-Handpiece,angled,95mm,80k HS-Handpiece,angled,125mm,80k HS-Handpiece,angled,150mm,80k
- Model Identifier(s)
- 362645 362680 362681 362682 362683 362684
About this record
Access comprehensive regulatory information for Bien Air Surgery High-Speed 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 DE0510248 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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