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HSA · registration DE0510251

Bien Air Surgery Micro Ear Drill Instruments

SingaporeEar, Nose & ThroatClass BBien Air Surgery SA
Verified
Official record identity
Registration number
DE0510251
Model name
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
460203; 460206; 460207; 460208; 460210; 460212; 460214; 460218; 460223; 460805; 460806; 460807; 460808; 460810; 460814; 460818; 460823
Registration date
January 16, 2025
Source update date
April 22, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Ear, Nose & Throat
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Published parties
Product owner
Bien Air Surgery SA
Registrant / registration holder
KARL STORZ ENDOSCOPY SINGAPORE SALES PTE. LTD.
Official description

The Micro Ear Drill instruments are intended for the light drilling of ossicle 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.