HSA · registration DE0510250

Bien Air Surgery Micro Ear Drill

Name: Bien Air Surgery Micro Ear Drill — HSA DE0510250
Creator: Bien Air Surgery SA
Keywords: Bien Air Surgery Micro Ear Drill, Bien Air Surgery Micro Ear Drill, DE0510250, Ear, Nose & Throat, HSA

SingaporeEar, Nose & ThroatClass BBien Air Surgery SA

Verified

Official record identity

Registration number: DE0510250
Model name: Micro Ear Drill, 12k
Model identifier: 460000
Registration date: January 16, 2025
Source update date: April 22, 2025

Classification

Risk class: Class B
Published category: Ear, Nose & Throat

Published parties

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

Official description

The Micro Ear Drill is an active medical device that convert electrical energy into mechanical rotation to a bur during ear surgery.

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.