Singapore HSA registration DE0510247

Bien Air Surgery High Speed Burrs (Reusable)

Singapore·CLASS B·Bien Air Surgery SA·Registered January 16, 2025

Device classification

Device Class: CLASS B
Medical Speciality Area: General & Plastic Surgery

Registration information

Registration Number: DE0510247
Registration Date: January 16, 2025
Retention Due Date: January 15, 2026

Product description

High speed burs are intended to cut and shape 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): HS Stand. Burr, Ø0.8x70, 50k HS Stand. Burr, Ø1.0x70, 50k HS Stand. Burr, Ø1.4x70, 50k HS Stand. Burr, Ø1.8x70, 50k HS Stand. Burr, Ø2.3x70, 50k HS Stand. Burr, Ø2.7x70, 50k HS Stand. Burr, Ø3.1x70, 50k HS Stand. Burr, Ø3.5x70, 50k HS Stand. Burr, Ø4.0x70, 50k HS Stand. Burr, Ø5.0x70, 50k HS Stand. Burr, Ø6.0x70, 50k HS Stand. Burr, Ø7.0x70, 50k HS Diam. Burr, Ø0.6x70, 50k HS Diam. Burr, Ø0.8x70, 50k HS Diam. Burr, Ø1.0x70, 50k HS Diam. Burr, Ø1.4x70, 50k HS Diam. Burr, Ø1.8x70, 50k HS Diam. Burr, Ø2.3x70, 50k HS Diam. Burr, Ø2.7x70, 50k HS Diam. Burr, Ø3.1x70, 50k HS Diam. Burr, Ø3.5x70, 50k HS Diam. Burr, Ø4.0x70, 50k HS Diam. Burr, Ø5.0x70, 50k HS Diam. Burr, Ø6.0x70, 50k HS Diam. Burr, Ø7.0x70, 50k HS Dia.Burr,coarse,Ø2.3x70,50k HS Dia.Burr,coarse,Ø2.7x70,50k HS Dia.Burr,coarse,Ø3.1x70,50k HS Dia.Burr,coarse,Ø3.5x70,50k HS Dia.Burr,coarse,Ø4.0x70,50k HS Dia.Burr,coarse,Ø5.0x70,50k HS Dia.Burr,coarse,Ø6.0x70,50k Tungst.Carb.Burr,Ø0.5x70mm,50k Tungst.Carb.Burr,Ø0.8x70mm,50k Tungst.Carb.Burr,Ø1.0x70mm,50k Tungst.Carb.Burr,Ø1.4x70mm,50k Tungst.Carb.Burr,Ø1.8x70mm,50k Tungst.Carb.Burr,Ø2.3x70mm,50k Tungst.Carb.Burr,Ø2.7x70mm,50k Tungst.Carb.Burr,Ø3.1x70mm,50k Tungst.Carb.Burr,Ø3.5x70mm,50k Tungst.Carb.Burr,Ø4.0x70mm,50k Tungst.Carb.Burr,Ø5.0x70mm,50k Tungst.Carb.Burr,Ø6.0x70mm,50k Tungst.Carb.Burr,Ø7.0x70mm,50k
Model Identifier(s): 340108 340110 340114 340118 340123 340127 340131 340135 340140 340150 340160 340170 340206 340208 340210 340214 340218 340223 340227 340231 340235 340240 340250 340260 340270 340323 340327 340331 340335 340340 340350 340360 340805 340808 340810 340814 340818 340823 340827 340831 340835 340840 340850 340860 340870

About this record

Access comprehensive regulatory information for Bien Air Surgery High Speed Burrs (Reusable) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510247 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