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Singapore HSA registration DE0510251

Bien Air Surgery Micro Ear Drill Instruments

Singapore flagSingapore·CLASS B·Bien Air Surgery SA·Registered January 16, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0510251
Registration Date
January 16, 2025
Change Notification Approval Date
April 22, 2025
Retention Due Date
January 15, 2026
Product description
The Micro Ear Drill instruments are intended for the light drilling of ossicle bones
Product Owner
Name
Bien Air Surgery SA
Short Name
Bien Air Surgery SA
Address
Rue de l'Ouest 2b,, 2340 Le Noirmont, SWITZERLAND
Registrant
Name
KARL STORZ ENDOSCOPY SINGAPORE SALES PTE. LTD.
Address
8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Importer
Name
KARL STORZ ENDOSCOPY ASIA MARKETING PTE. LTD. KARL STORZ ENDOSCOPY SINGAPORE SALES PTE. LTD.
Address
8 COMMONWEALTH LANE, GRANDE BUILDING, #03-02, SINGAPORE 149555 8 COMMONWEALTH LANE, #03-02/03, SINGAPORE 149555
Model information
Model Name(s)
Dia.Perf.Mic-Ear-Bur,Ø0.35,12k Diam. Micro-Ear-Burr,Ø0.6,12k Diam. Micro-Ear-Burr,Ø0.7,12k Diam. Micro-Ear-Burr,Ø0.8,12k Diam. Micro-Ear-Burr,Ø1.0,12k Diam. Micro-Ear-Burr,Ø1.2,12k Diam. Micro-Ear-Burr,Ø1.4,12k Diam. Micro-Ear-Burr,Ø1.8,12k Diam. Micro-Ear-Burr,Ø2.3,12k T.Carb.Micro-Ear-Burr,Ø0.5,12k T.Carb.Micro-Ear-Burr,Ø0.6,12k T.Carb.Micro-Ear-Burr,Ø0.7,12k T.Carb.Micro-Ear-Burr,Ø0.8,12k T.Carb.Micro-Ear-Burr,Ø1.0,12k T.Carb.Micro-Ear-Burr,Ø1.4,12k T.Carb.Micro-Ear-Burr,Ø1.8,12k T.Carb.Micro-Ear-Burr,Ø2.3,12k
Model Identifier(s)
460203 460206 460207 460208 460210 460212 460214 460218 460223 460805 460806 460807 460808 460810 460814 460818 460823
About this record

Access comprehensive regulatory information for Bien Air Surgery Micro Ear Drill Instruments in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510251 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