Singapore HSA registration DE0510257
Bien Air Surgery Perforator Handpiece
Singapore·CLASS B·Bien Air Surgery SA·Registered January 17, 2025Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0510257
- Registration Date
- January 17, 2025
- Change Notification Approval Date
- April 22, 2025
- Retention Due Date
- January 16, 2026
Product description
The perforator is an active medical device intended to convert electrical energy to mechanically drive perforator tools for drilling cranium bone.
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)
- Perforator Handpiece Perforator Motor Cable for Perforator Motor
- Model Identifier(s)
- 362640 362641 362642
About this record
Access comprehensive regulatory information for Bien Air Surgery Perforator Handpiece in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510257 and owned by Bien Air Surgery SA. The device was registered on January 17, 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