HSA · registration DE0510246

Bien Air Surgery High Speed Burrs (Single use, sterile)

Name: Bien Air Surgery High Speed Burrs (Single use, sterile) — HSA DE0510246
Creator: Bien Air Surgery SA
Keywords: Bien Air Surgery High Speed Burrs (Single use, sterile), Bien Air Surgery High Speed Burrs (Single use, sterile), DE0510246, General & Plastic Surgery, HSA

SingaporeGeneral & Plastic SurgeryClass BBien Air Surgery SA

Verified

Official record identity

Registration number: DE0510246
Model name: HS Stand. Burr, Ø2.3x70, 80k; HS Stand. Burr, Ø2.3x125, 80k; HS Stand. Burr, Ø2.3x95, 80k; HS Stand. Burr, Ø3.1x70, 80k; HS Stand. Burr, Ø3.1x150, 80k; HS Stand. Burr, Ø3.1x125, 80k; HS Stand. Burr, Ø3.1x95, 80k; HS Stand. Burr, Ø4.0x70, 80k; HS Stand. Burr, Ø4.0x150, 80k; HS Stand. Burr, Ø4.0x125, 80k; HS Stand. Burr, Ø4.0x95, 80k; HS Stand. Burr, Ø5.0x70, 80k; HS Stand. Burr, Ø5.0x150, 80k; HS Stand. Burr, Ø5.0x125, 80k; HS Stand. Burr, Ø5.0x95, 80k; HS Stand. Burr, Ø6.0x70, 80k; HS Stand. Burr, Ø6.0x125, 80k; HS Stand. Burr, Ø7.0x70, 80k; HS Diam. Burr, Ø1.0x70, 80k; HS Diam. Burr, Ø1.0x150, 80k; HS Diam. Burr, Ø1.0x125, 80k; HS Diam. Burr, Ø1.0x95, 80k; HS Diam. Burr, Ø1.8x150, 80k; HS Diam. Burr, Ø2.0x70, 80k; HS Diam. Burr, Ø2.3x125, 80k; HS Diam. Burr, Ø2.3x95, 80k; HS Diam. Burr, Ø2.5x70, 80k; HS Diam. Burr, Ø3.1x70, 80k; HS Diam. Burr, Ø3.1x150, 80k; HS Diam. Burr, Ø3.1x125, 80k; HS Diam. Burr, Ø3.1x95, 80k; HS Diam. Burr, Ø4.0x70, 80k; HS Diam. Burr, Ø4.0x150, 80k; HS Diam. Burr, Ø4.0x125, 80k; HS Diam. Burr, Ø5.0x70, 80k; HS Dia.Burr,coarse,Ø2.3x70,80k; HS Dia.Burr,coarse,Ø3.1x70,80k; HS Dia.Bur,coarse,Ø3.1x150,80k; HS Dia.Bur,coarse,Ø3.1x125,80k; HS Dia.Burr,x-crse,Ø4.0x70,80k; HS Dia.Bur,coarse,Ø4.0x150,80k; HS Dia.Bur,coarse,Ø4.0x125,80k; HS Dia.Burr,coarse,Ø4.0x95,80k; HS Dia.Bur,coarse,Ø5.0x150,80k; HS Dia.Bur,coarse,Ø5.0x125,80k; HS Dia.Burr,coarse,Ø5.0x95,80k; HS Craniotome Burr, long 80k; HS Craniotome Burr,medium,80k; HS Craniotome Burr, short, 80k; HS Dia.Bur,x-crse,Ø4.7x125,80k
Model identifier: 360123ES; 360123M; 360123S; 360131ES; 360131L; 360131M; 360131S; 360140ES; 360140L; 360140M; 360140S; 360150ES; 360150L; 360150M; 360150S; 360160ES; 360160M; 360170ES; 360210ES; 360210L; 360210M; 360210S; 360218L; 360220ES; 360223M; 360223S; 360225ES; 360231ES; 360231L; 360231M; 360231S; 360240ES; 360240L; 360240M; 360250ES; 360323ES; 360331ES; 360331L; 360331M; 360340ES; 360340L; 360340M; 360340S; 360350L; 360350M; 360350S; 362640L; 362640M; 362640S; 363347M
Registration date: January 16, 2025

Classification

Risk class: Class B
Published category: General & Plastic Surgery

Published parties

Product owner: Bien Air Surgery SA
Registrant / registration holder: KARL STORZ ENDOSCOPY SINGAPORE SALES PTE. LTD.

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.