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Bien Air Surgery Micro Ear Drill - HSA Registration DE0510250

Access comprehensive regulatory information for Bien Air Surgery Micro Ear Drill in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510250 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
DE0510250
Bien Air Surgery Micro Ear Drill
HSA Registration Number: DE0510250
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Product Description

The Micro Ear Drill is an active medical device that convert electrical energy into mechanical rotation to a bur during ear surgery.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0510250
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)
Micro Ear Drill, 12k
Model Identifier(s)
460000