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Singapore HSA registration DE0510115

Bien Air Surgery Micromotors and Cables

Singapore flagSingapore·CLASS B·Bien Air Surgery SA·Registered December 05, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration information
Registration Number
DE0510115
Registration Date
December 05, 2024
Change Notification Approval Date
April 22, 2025
Retention Due Date
December 04, 2025
Product description
The High speed micromotors small 20363033, large 20362033 and INTRA-80K 20261033 are active medical devices intended to convert electrical energy to mechanically drive handpieces and craniotome for cutting and shaping bone.
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)
INTRA Motor-80k, without Cable Connecting Cable INTRA High-Speed Micro-Motor without cable Cable for HS-Micro-Motor,large High-Speed Micro-Motor without cable Cable for HS-Micro-Motor,small
Model Identifier(s)
20261133 20261233 20362133 20362233 20363133 20363233
About this record

Access comprehensive regulatory information for Bien Air Surgery Micromotors and Cables in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510115 and owned by Bien Air Surgery SA. The device was registered on December 05, 2024.

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