Pure Global AI
HSA · registration DE0510247

Bien Air Surgery High Speed Burrs (Reusable)

SingaporeGeneral & Plastic SurgeryClass BBien Air Surgery SA
Official record identity
Registration number
DE0510247
Model name
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
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
Registration date
January 16, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
General & Plastic Surgery
Published parties
Official description

High speed burs are intended to cut and shape bones.

Additional source fields
Product owner address
Rue de l'Ouest 2b,, 2340 Le Noirmont, Switzerland
Registrant address
438B ALEXANDRA ROAD, #02-07, ALEXANDRA TECHNOPARK, Singapore 119968
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.