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Bien Air Surgery Perforator Handpiece - HSA Registration DE0510257

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.

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CLASS B
DE0510257
Bien Air Surgery Perforator Handpiece
HSA Registration Number: DE0510257
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Product Description

The perforator is an active medical device intended to convert electrical energy to mechanically drive perforator tools for drilling cranium bone.

Device 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 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